MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADJUSTING DEVICE TIBIA T2 ALPHA? TIBIA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-4105
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the adjusting device could not be attached to the distal targeting arm when inserting the distal screw with the distal device.The procedure was performed using a freehand technique." additionally, it was reported; the procedure was extended however the length of the extension is unknown and there was additional exposure to radiation.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the adjusting device could not be attached to the distal targeting arm when inserting the distal screw with the distal device.The procedure was performed using a freehand technique." additionally, it was reported; the procedure was extended however the length of the extension is unknown and there was additional exposure to radiation.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the center bolt has marks of abrasion indicating intensive usage.An imprint of the locking pin which locks the bolt with the frame can be seen suggesting that the pin has loosened.Overall, there are no major damages visible on the device.A functional test was performed by assembling the returned adjusting device with a sample distal targeting arm.It was observed that the adjusting device could not be attached to the distal targeting device.The center bolt was loose as opposed to being fixed in one place.Consequently, the hook at the distal end could not properly lock and clamp with the targeting arm.Hence the alleged issue could be confirmed.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.The above investigation reveals the issue to be potential manufacturing issue.An nc has been raised to address and investigate the issue further.The record will be updated once more information is received.If any further information is provided, the complaint report will be updated.

• Brand Name: ADJUSTING DEVICE TIBIA T2 ALPHA? TIBIA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 14219264
• Report Number: 0009610622-2022-00153
• Device Sequence Number: 17470149
• Product Code: HSB
• UDI-Device Identifier: 07613327357073
• UDI-Public: 07613327357073
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• 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): 10/10/2022

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: 2353-4105
• Device Catalogue Number: 23534105
• Device Lot Number: KME912786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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