MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN WIRE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3040
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported the following: "one wire broke and we miss the jig three times at the very end after many attempts throughout the surgery.The broken wire intra op that we could not remove, and also, a missing attempt to pass the wire through the nail x3." update : ((b)(6) 2021) the procedure was completed successfully.However, only one screw was placed on the femoral head, as the broken wire was on the trajectory of the second screw.The procedure was delayed by 42 minutes.
Additional Manufacturer Narrative
Correction: please refer to d1 product long description, d4 catalog, lot & gtin number, d9/h3 -product not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If any further information is provided, the investigation report will be reassessed.H3 other text: device disposition is unknown.
Event or Problem Description
It was reported the following: "one wire broke and we miss the jig three times at the very end after many attempts throughout the surgery.The broken wire intra op that we could not remove, and also, a missing attempt to pass the wire through the nail x3." update : (16/11/21) the procedure was completed successfully.However, only one screw was placed on the femoral head, as the broken wire was on the trajectory of the second screw.The procedure was delayed by 42 minutes.

• Brand Name: UNKNOWN WIRE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12959441
• Report Number: 0009610622-2021-00808
• Device Sequence Number: 1855141
• Product Code: LXH
• UDI-Device Identifier: 04546540414625
• UDI-Public: 04546540414625
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/24/2022

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 Model Number: 1806-3040
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown