MAUDE Adverse Event Report: STRYKER GMBH PLATE ADAPTER DIST. LAT. FEMUR RIGHT; PLATE, FIXATION, BONE

Model Number	703522
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Rep left a voicemail saying the threads of the devices stripped intra-operatively.

• Brand Name: PLATE ADAPTER DIST. LAT. FEMUR RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9827488
• Report Number: 0008031020-2020-00690
• Device Sequence Number: 726991
• Product Code: HRS
• UDI-Device Identifier: 04546540693600
• UDI-Public: 04546540693600
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181091
• 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
• Report Date (Section B): 03/12/2020

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: 703522
• Device Catalogue Number: 703522
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1