MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT STERILE CASE, COMPLETE; HIP INSTRUMENTS : INSTRUMENT CASES

Catalog Number	257010000
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
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
After instrument tray was used in surgery, sterilization noticed a plastic part at the bottom of the tray.It is plastic covering metal parts that is peeling off.No parts were seen during surgery, so no harm to patient.It seems this occured after surgery while going through cleaning process.
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.Examination of the returned instrument confirmed the complaint.The root cause is attributed to 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.Johnson & johnson canada reports after instrument tray was used in surgery, sterilisation noticed a plastic part at the bottom of the tray.It is plastic covering metal parts that is peeling off.No parts were seen during surgery, so no harm to patient.It seems this occured after surgery while going through cleaning process.Examination of the returned case confirmed the complaint.The black coating on the handle bracket has peeled off.Also, the bottom portion of the reamer brackets is peeling off.A search of the complaint database found similar reports for peeling that were attributed to heavy usage/wear out.The search did not identify a trend for peeling material.The lot number for the base is cf6b54.Review of the as400 found this lot was manufactured in 2008 and is 11-years old.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under post market surveillance sep 419.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.
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.  additional narrative:   added: device identification, concomitant medical products and device manufacture date.Corrected: device evaluated by mfr.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT STERILE CASE, COMPLETE
• Common Device Name: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9123914
• Report Number: 1818910-2019-106396
• Device Sequence Number: 11343602
• Product Code: FSM
• UDI-Device Identifier: 10603295143659
• UDI-Public: 10603295143659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2019

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: 257010000
• Device Lot Number: CF6B54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/20/2019; 11/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/26/2019; 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1