MAUDE Adverse Event Report: STRYKER GMBH OLECRANON PLATE VARIAX FOR RIGHT ULNA 3 HOLE / L65MM; PLATE, FIXATION, BONE

Model Number	629363S
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
Event or Problem Description
Screw could not be locked into the variax plate.Attempted to insert another screw but could not be locked.

• Brand Name: OLECRANON PLATE VARIAX FOR RIGHT ULNA 3 HOLE / L65MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7397536
• Report Number: 0008031020-2018-00269
• Device Sequence Number: 13623195
• Product Code: HRS
• UDI-Device Identifier: 07613327088397
• UDI-Public: (01)07613327088397
• Combination Product (Y/N): N
• PMA/510(K) Number: K141677
• 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
• Report Date (Section B): 04/04/2018

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 Expiration Date: 04/30/2021
• Device Model Number: 629363S
• Device Catalogue Number: 629363S
• Device Lot Number: V19359
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/04/2018
• 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: Other
• Patient Age: 81 YR