QUICKSET DEPTH GAUGE 70MM
Received Aug 19, 2020 · Event occurred Aug 11, 2020
Report 1818910-2020-18447 · MDR key 10428151
Device
Generic name
Hip Instruments : Drill Guides
Manufacturer
Depuy Orthopaedics Inc UsModel number
2274-60-000Catalog number
227460000
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY.
Additional Manufacturer Narrative
(B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN THE SETS. TIP OF THE BIMENTUM PLASTIC INSERT WAS BROKEN OFF AT THE BASE. BOTH DEPTH GAUGES ARE SHEARED OFF AT THE BASE. NO SURGICAL DELAY.