MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM T2 ANKLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-3212
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that patient presented post op.Upon x-ray it was noted that the screw missed the nail using the outrigger and ended up causing a fracture.Allegedly, the patient may need to undergo a second surgery.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: we received a targeting arm in good condition for evaluation.The devices showed typical signs of use but were generally undamaged.No visible signs of misuse or remarkable damages were found.A pre-surgical function test was performed on the returned devices.The nail adapter can be easily assembled with the targeting arm without any effort.Hence the alleged misdrilling could not be reproduced.The function of the returned instrument was given in all aspects.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the alleged misdrilling could not be reproduced, and hence could not be confirmed.Therefore, a real root cause for the alleged misdrilling could not be determined.Most likely the issue is user related.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that patient presented post op.Upon x-ray it was noted that the screw missed the nail using the outrigger and ended up causing a fracture.Allegedly, the patient may need to undergo a second surgery.

• Brand Name: TARGETING ARM T2 ANKLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel TN D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel TN D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16572222
• Report Number: 3010667733-2023-00130
• Device Sequence Number: 12071819
• Product Code: LXH
• UDI-Device Identifier: 04546540708496
• UDI-Public: 04546540708496
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1806-3212
• Device Catalogue Number: 18063212
• Device Lot Number: KME916143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown