MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US REPL TIP FEMORAL HD IMPACTOR; EXTREMITY INSTRUMENTS : IMPACTORS

Model Number 2001-66-000

Device Problems Material Twisted/Bent (2981); Naturally Worn (2988); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.The root cause is attributed to heavy usage and wear out.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Surgeons are starting to complain that the poly tips on the head impactors are worn out and should be replaced.All question of normal wear, doing more than 400 hips a year.No patient damage, but want them to be exchanged before they cause damage.No delays in surgeries.Just a case of normal wear.Pls replace asap (b)(6).Patient consequence? :no.

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.H10 additional narrative: added: h6 product complaint #
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> (b)(4).Investigation summary
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> examination of the returned instrument confirmed the reported observation.The root cause is attributed to heavy usage and wear out.Depuy 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.Device history lot
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> null device history batch
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> null device history review
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> null 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: REPL TIP FEMORAL HD IMPACTOR
• Type of Device: EXTREMITY INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9281285
• MDR Text Key: 184850542
• Report Number: 1818910-2019-114220
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 10603295080138
• UDI-Public: 10603295080138
• Combination Product (y/n): N
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2001-66-000
• Device Catalogue Number: 200166000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1