MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1210-6450
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cutter got stuck on a third party attachment.The third party technician stated that the cutter might have contributed to the malfunction.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Additional Manufacturer Narrative
The reported event was confirmed on provided image.The stryker k-wire was stuck in a non-stryker adapter.A review of the device history could not be performed as the lot code could not be identified.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The ifu states: ¿ stryker surgical instruments are intended to be used in surgical procedures in conjunction with stryker implants which come with package inserts of their own.¿ thus, the item was not used according to the instruction; the event was caused by off-label use.In case substantive information or the item itself becomes available we reserve the right to reopen the investigation and to reassess the root cause.
Event or Problem Description
It was reported that cutter got stuck on a third party attachment.The third party technician stated that the cutter might have contributed to the malfunction.

• Brand Name: K-WIRE GAMMA Ø3,2X450 MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13257205
• Report Number: 0009610622-2022-00016
• Device Sequence Number: 14642748
• Product Code: LXH
• UDI-Device Identifier: 04546540175359
• UDI-Public: 04546540175359
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 1210-6450
• Device Catalogue Number: 12106450
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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