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

Catalog Number	23534107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
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: "surgeon was impacting nail and a piece of the knob on the targeting arm broke".Procedure was completed successfully with no adverse consequences or surgical delay reported.
Event or Problem Description
As reported: "surgeon was impacting nail and a piece of the knob on the targeting arm broke".Procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
Correction: section d4 (lot# & serial#).The reported event could be confirmed, since the device was returned and matched the reported failure mode.Visual inspection: the grey knob was damaged and fully broken out.Detailed inspection of the breakage surfaces revealed a brittle fracture.During manufacturing, functionality test and dimensional inspection were done according to specifications.During the inspection, all devices met the specifications.Incoming inspection and the device history record of the reported tibia target device revealed no manufacturing discrepancies.Further investigation determined that the crack was caused by a manufacturing agent used by a contract manufacturer.This is being investigated as a nonconformity.

• Brand Name: TARGETING ARM 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
• MDR Report Key: 8664432
• Report Number: 0009610622-2019-00468
• Device Sequence Number: 1941334
• Product Code: HSB
• UDI-Device Identifier: 07613327357080
• UDI-Public: 07613327357080
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K180436
• 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): 09/25/2019

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 Catalogue Number: 23534107
• Device Lot Number: KME912402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1