MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK KIT/SET; GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS

Model Number 1137-12-000

Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2020

Event Type  malfunction  

Manufacturer Narrative

(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

The ¿packaging¿ that surrounded the box and that guarantees the sterility of the materials was damaged and, as reported below, was alerted by our technical assistant, where the correct conduct of the hospital should have been to reprocess the material before the start of surgery.The box with the damaged ¿packaging¿ referred only to the main instruments that would be used in surgery; other disposable materials and implants were in compliance.

Event Description

Further follow-up with the reporter has indicated that the reported products were instrumentation which is sold non-sterile.The issue reported was not a device related problem.

Manufacturer Narrative

Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.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.

• Brand Name: UNK KIT/SET
• Type of Device: GLOBAL ADVANTAGE IMPLANT : SHOULDER HUMERAL STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9930454
• MDR Text Key: 190631057
• Report Number: 1818910-2020-10307
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295007142
• UDI-Public: 10603295007142
• Combination Product (y/n): N
• PMA/PMN Number: K992065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1137-12-000
• Device Catalogue Number: UNK KIT/SET
• Device Lot Number: D19021836
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR