MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW, T8 FULL THREAD, 2.7MM/L32MM; SCREW, FIXATION, BONE

Model Number	656432
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.One half implanted, the other half was discarded.
Event or Problem Description
As reported: "drill tip broke off while drilling 5th out of 6 holes, variax 2 screw head came off when final tightening into plate, and axsos screw head broke while implanting." rep reported that the procedure was a revision due to "nonunion of distal femur fracture." with complicating condition "above implant femur shaft fracture along with nonunion.".

• Brand Name: BONE SCREW, T8 FULL THREAD, 2.7MM/L32MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9718099
• Report Number: 0008031020-2020-00447
• Device Sequence Number: 11351016
• Product Code: HWC
• UDI-Device Identifier: 07613327068986
• UDI-Public: 07613327068986
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: 656432
• Device Catalogue Number: 656432
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR