BATTERY OSCILLATOR II FOR BPL II
Received Jul 31, 2026 · Event occurred Jan 1, 2026
Report 8030965-2026-07864 · MDR key 50097184
Device
Product problems
- Physical Resistance/Sticking
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during service and repair pre-testing, it was discovered that the battery oscillator device had a sticky trigger. This event did not occur during surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H10 Additional Narrative:This device was returned for service; however, it did not meet manufacturing specifications during pre-repair assessment. However, since the investigation is still on-going, the assignable root cause could not be determined at this time. Once investigation has been completed, a Supplemental Medwatch will be submitted accordingly.