MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP, STD, TI GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30051100S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.
Event or Problem Description
It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise, the investigation will be updated accordingly.

• Brand Name: END CAP, STD, TI GAMMA3®
• 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: 8483027
• Report Number: 0009610622-2019-00136
• Device Sequence Number: 1576520
• Product Code: HSB
• UDI-Device Identifier: 04546540374851
• UDI-Public: 04546540374851
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2019

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 Catalogue Number: 30051100S
• Device Lot Number: K05277E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Weight: 48