MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW IMN SCREWS Ø5X75MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23605075S
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	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
During inbound process it was noticed that item was received with hair under sealing foil.
Event or Problem Description
During inbound process it was noticed that item was received with hair under sealing foil.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned device could be confirmed based on the catalog and lot number marked on the packaging labeling.The packaging was confirmed to be complete and sealed, it was not modified in any way.The presence of a hair could be confirmed under the external plastic foil (not in contact with the product itself).Based on investigation, the root cause was attributed to a manufacturing issue.The failure was caused by not detected pollution during inspection at time of packaging steps.A nc was initiated in order to cover the reported issue.A review of the labeling did not indicate any abnormalities.If more information is provided, the case will be reassessed.

• Brand Name: LOCKING SCREW IMN SCREWS Ø5X75MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19559814
• Report Number: 0009610622-2024-00287
• Device Sequence Number: 4733699
• Product Code: HSB
• UDI-Device Identifier: 07613327368536
• UDI-Public: 07613327368536
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K191271
• 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,Followup
• Report Date (Section B): 08/27/2024

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: 23605075S
• Device Lot Number: K1AD966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• 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