MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX HA-COATED Ø 6MM, 180 X 30MM; PIN, FIXATION, THREADED

Catalog Number	50143180S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that indeed a foreign body is visible between the vinyl shrink wrap and the carton packaging, most likely it is a hair.Inspection of the received information/evidences are done or will be done, in the proceedings of the non-conformity.Based on investigation, the root cause was attributed to a manufacturing issue.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "during inbound processing, it was noticed hair under the shrink wrap.".

• Brand Name: SELF-DRILLING HALF PIN APEX HA-COATED Ø 6MM, 180 X 30MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18970297
• Report Number: 0008031020-2024-00141
• Device Sequence Number: 6213707
• Product Code: JDW
• UDI-Device Identifier: 07613154493142
• UDI-Public: 07613154493142
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K061493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: Other
• Device Catalogue Number: 50143180S
• Device Lot Number: AE6208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown