S-ROM*PIN PUNCH
Received Mar 24, 2022 · Event occurred Mar 8, 2022
Report 1818910-2022-05360 · MDR key 13890755
Device
Generic name
Hip Instruments : Tamps
Manufacturer
Depuy Orthopaedics Inc UsModel number
53-1500Catalog number
531500
Product problems
- Material Deformation
- Material Deformation
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE VERSION PIN GOT BENT AND NEEDS TO BE REPLACED.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4).
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.
Description of Event or Problem
THERE WAS NO SURGICAL DELAY.