MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V2 - RIGHT; PLATE, FIXATION, BONE

Catalog Number	PLP11342
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The following event was reported by clinic: despite the use of the barrel on the plate anchorage mtp right (ref plp11342), the screw diameter 3 locking does not fit correctly in the hole.Threading problem was observed and 1 wire came out of the screw.The screw protrudes from the plate and a metal wire comes out of the screw.The screw was removed and another screw reinserted.
Event or Problem Description
The following event was reported by clinic: " despite the use of the barrel on the plate anchorage mtp right (ref plp11342), the screw diameter 3 locking does not fit correctly in the hole.Threading problem was observed and 1 wire came out of the screw.The screw protrudes from the plate and a metal wire comes out of the screw.The screw was removed and another screw reinserted.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: PLATE ANCHORAGE MTP / VERSION V2 - RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8356235
• Report Number: 0008031020-2019-00070
• Device Sequence Number: 1599679
• Product Code: HRS
• UDI-Device Identifier: 07613252260516
• UDI-Public: 07613252260516
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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: PLP11342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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: Other