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

Model Number	1210-6450S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "first surgery was performed in (b)(6) (de26040).The tip of the k-wire broke off.This was not removed in sande.According to the surgeon, the patient was in pain.The tip was removed arthroscopically in hospital ev oldenburg (surgery time 1 hour).This was on (b)(6) 2023.X-ray images are available! item was disposed by customer after revision.
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity).The received x-rays were reviewed, it can be confirmed that the threaded tip of the k-wire is broken off and did remain in the patient.A device inspection was not possible since the affected device was not returned and therefore no further evaluation is possible.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.The affected device must be available in order to determine the root cause of the complaint event, only based on the available information it cannot be determined whether the in the operation report mentioned too dorsal position of the k-wire played a role.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "first surgery was performed in hospital sande (b)(6).The tip of the k-wire broke off.This was not removed in sande.According to the surgeon, the patient was in pain.The tip was removed arthroscopically in hospital ev oldenburg (surgery time 1 hour).This was on (b)(6) 2023.X-ray images are available! item was disposed by customer after revision.
Additional Manufacturer Narrative
Please note corrections to h6 (imdrf clinical signs code and health impact code).
Event or Problem Description
As reported: "first surgery was performed in hospital sande ((b)(6)).The tip of the k-wire broke off.This was not removed in sande.According to the surgeon, the patient was in pain.The tip was removed arthroscopically in hospital ev oldenburg (surgery time 1 hour).This was on (b)(6) 2023.X-ray images are available! item was disposed by customer after revision.

• Brand Name: K-WIRE GAMMA Ø3,2X450 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16942861
• Report Number: 0009610622-2023-00153
• Device Sequence Number: 19699519
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 08/22/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 06/30/2023; 09/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown