MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRIAL SHELL 64 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221701064
Medical Device Problem Codes	Corroded (1131); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
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
Describe event: after surgery within multiple hospital, in 4 orthokits we have found out that the xxx are have oxidated around the incaved letters and numbers when did the device problem occur? after using the orthokits for surgery.Some has rust, some has not.Is this report related to a piece of capital equipment? yes.Did the event occur during a procedure/surgery? no.Procedure/surgery name arthroplasty? procedure/surgery date n/a, multi hospitals has used it? what action was taken/required to manage the problem during the procedure ? all the grater heads in different sizes which show oxidation around the letters/numbers will be replaced,but are in back order for a long time.We cannot use the kits for surgery.
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: no products were returned for investigation.Without further information the cause of the rusting to these products cannot be confirmed and so the complaint will be closed to an undetermined conclusion.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.

• Brand Name: PIN TRIAL SHELL 64 STD PROFILE
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8857292
• Report Number: 1818910-2019-99981
• Device Sequence Number: 14082274
• Product Code: LXH
• UDI-Device Identifier: 10603295097754
• UDI-Public: 10603295097754
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 07/15/2019

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: 221701064
• Device Lot Number: SO2021454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 09/30/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/13/2019; 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1