MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNK KIT/SET; GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID

Model Number	1136-40-026
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Event or Problem 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.

• Brand Name: UNK KIT/SET
• Common Device Name: GLENOID (STEPTECH AND ANCHOR PEG) : SHOULDER GLENOID
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• MDR Report Key: 9930397
• Report Number: 1818910-2020-10305
• Device Sequence Number: 16727848
• Product Code: KWS
• UDI-Device Identifier: 10603295006954
• UDI-Public: 10603295006954
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K052472
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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 Expiration Date: 04/30/2021
• Device Model Number: 1136-40-026
• Device Catalogue Number: UNK KIT/SET
• Device Lot Number: C38412
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR