MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP PIN IMPACTOR/EXTRACTOR; KNEE INSTRUMENT : EXTRACTION INSTRUMENTS

Catalog Number	950502070
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The instrument is no longer able to extract the pin.No surgery delay, no adverse consequences for patient.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # = > (b)(4).Investigation summary = > the complaint sample consists of (1) (b)(4) hp pin impactor/extractor, lot code so2029194.Examination of the returned hp pin impactor/extractor revealed the two screws that attach the two springs to the device are 90% disassembled.The partially disassembled screws prohibit the device¿s springs from functioning properly as reported.The position of the screws suggests the device has been disassembled for an unknown reason.The device is not design to be disassembled for cleaning or any other reason.There is general wear and tear on various areas of the device indicating usage in multiple previous surgeries.A worldwide complaint database search found no additional reports against the complaint sample product code/lot code combination.The root cause is being attributed to misuse and the need for corrective action is not indicated.Complaint trends will be monitored by post market surveillance through sep-419.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HP PIN IMPACTOR/EXTRACTOR
• Common Device Name: KNEE INSTRUMENT : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8562224
• Report Number: 1818910-2019-91914
• Device Sequence Number: 1587123
• Product Code: LXH
• UDI-Device Identifier: 10603295227861
• UDI-Public: 10603295227861
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/09/2019

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 Catalogue Number: 950502070
• Device Lot Number: SO2029194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1