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	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the pin of adjusting device (#23534105/lot 261507) was missing during the procedure.".
Additional Manufacturer Narrative
The evaluation revealed the adjusting device to be the primary product; the tibial nail and the distal targeting arm were classified as concomitant items.No deviations were found during review of the manufacturing and inspection documents (dhr).The risk management file review showed that the complained event was addressed adequately; no threshold exceedances found.The inspection confirmed the reported event: the metal cylindric pin could be removed easily without resistance.The pin is not designed to be detachable; without the pin the adjusting device is not locked to the distal targeting arm, so a secure drilling and screw placement is not possible.The issue was already addressed by a non-conformity report; the nc investigation showed that the pin can fall of the guide block due to discrepancies in the design (transition fit instead of press fit).
Event or Problem Description
As reported: "the pin of adjusting device (#23534105/lot 261507) was missing during the procedure.".

• 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
• MDR Report Key: 10576687
• Report Number: 0009610622-2020-00542
• Device Sequence Number: 3507379
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: KME914880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1