MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLC HEX SCRDRVR SHAFT RIGID; HIP INSTRUMENTS : SCREWDRIVERS

Model Number	2274-04-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: per the complaint description, this device was returned with no alleged failure, sale rep sent for testing.Upon inspection, the hex tip is stripped.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.(b)(4).
Event or Problem Description
The primary surgery was performed on (b)(6) 2020 via tha.During the surgery, the handle (p/n: 227402000) and the quickset ratchet scdr hdl (p/n: 227408000) did not fit.The surgeon kept on using the handle and the screwdriver with unfitness to insert screws.Inserting screws was completed successfully.The surgery was completed within 30 minutes delay.The scrdrvr shaft rigid (p/n: 227404000) has no defect and it fitted to the handle with no problem, but the sales rep will ship it to test.No further information is available.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: d4 (lot #) if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DLC HEX SCRDRVR SHAFT RIGID
• Common Device Name: HIP INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10602883
• Report Number: 1818910-2020-21178
• Device Sequence Number: 11619219
• Product Code: HXX
• UDI-Device Identifier: 10603295109037
• UDI-Public: 10603295109037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2274-04-000
• Device Catalogue Number: 227404000
• Device Lot Number: A1007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1