MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US FEMORAL/HUMERAL HEAD IMPACTOR; EXTREMITY INSTRUMENTS : IMPACTORS

Model Number 2001-65-000

Device Problems Corroded (1131); Device Damaged by Another Device (2915); Material Deformation (2976); Material Twisted/Bent (2981); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

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 Description

It was reported that the white plastic screw on tip is damaged on impacting surface.Send replacement via fedex to (b)(6).No surgical delay.

Event Description

Additional information received that the surface should be smooth but is not.It is dented up pretty badly.

Manufacturer Narrative

Product complaint # (b)(4).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. .

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 device associated with this report was not returned, thus the reported event could not be confirmed.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and visual : corrosion/rusting/pitting were reviewed.It was determined visual : corrosion/rusting/pitting has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2018 ¿ july 12 2022.In total, there have been zero serious injuries and zero deaths reports related to visual : corrosion/rusting/pitting in the last 4.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, visual : corrosion/rusting/pitting associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.

• Brand Name: FEMORAL/HUMERAL HEAD IMPACTOR
• Type of Device: EXTREMITY INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9586179
• MDR Text Key: 189090867
• Report Number: 1818910-2020-01679
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295080121
• UDI-Public: 10603295080121
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/17/2019

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
• Device Operator: Health Professional
• Device Model Number: 2001-65-000
• Device Catalogue Number: 200165000
• Device Lot Number: SO2031724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 01/14/2020; 02/06/2020; 06/16/2022
• Supplement Dates FDA Received: 02/03/2020; 02/07/2020; 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1