MAUDE Adverse Event Report: STRYKER GMBH WIRE BOLT - MEDIUM HOFFMANN LRF FOR WIRE Ø1.5 TO 2.0MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	49331002
Medical Device Problem Codes	Break (1069); Fracture (1260); Off-Label Use (1494)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	07/10/2023
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
No event to report as of yet, awaiting further information.Update (b)(6) 2023:- "wire breakage".
Additional Manufacturer Narrative
Please note correction to h6 (device code).The complaint could be confirmed, as by the received products/construct, also a broken wire got received.The device inspection revealed the following: visual examination of the received products shows that they are in use, but otherwise in intact conditions.The washer (grey) is deformed, the deformation that can be seen is the result of an intended use, clamping of a wire.The wire which got used in connection with the stryker products is from competitor.The current instructions for use state: "do not use components of stryker product systems in conjunction with components from any other manufacturer¿s system unless otherwise specified." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
No event to report as of yet, awaiting further information.Update 11 jul 2023:- "wire breakage".
Event or Problem Description
No event to report as of yet, awaiting further information.Update 11 jul 2023:- "wire breakage".
Additional Manufacturer Narrative
Please note correction to h6 (clinical signs code).

• Brand Name: WIRE BOLT - MEDIUM HOFFMANN LRF FOR WIRE Ø1.5 TO 2.0MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 17461568
• Report Number: 0008031020-2023-00293
• Device Sequence Number: 20639369
• Product Code: KTT
• UDI-Device Identifier: 07613252507796
• UDI-Public: 07613252507796
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K113327
• 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,Followup
• Report Date (Section B): 11/14/2023

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: Lay User/Patient
• Device Catalogue Number: 49331002
• Device Lot Number: K59436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 11/07/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 11/03/2023; 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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