MAUDE Adverse Event Report: STRYKER GMBH PLATE ANCHORAGE MTP / VERSION V1 - RIGHT; PLATE, FIXATION, BONE

Catalog Number	PLP10342
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
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.Plate remained implanted.
Event or Problem Description
As reported: while implanting the anchorage plate, the doctor screwed the 3.0mm locking screws through the mtp v1 plate [three] times with only "two fingers" worth of force.This was 3 separate screws, each in a separate hole.None of the screws were explanted.The doctor just backed them up flush with the plate and left them in.
Event or Problem Description
As reported: while implanting the anchorage plate, the doctor screwed the 3.0mm locking screws through the mtp v1 plate [three] times with only "two fingers" worth of force.This was 3 separate screws, each in a separate hole.None of the screws were explanted.The doctor just backed them up flush with the plate and left them in.
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 V1 - RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7531482
• Report Number: 0008031020-2018-00372
• Device Sequence Number: 2018238
• Product Code: HRS
• UDI-Device Identifier: 07613252262138
• UDI-Public: 07613252262138
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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 Catalogue Number: PLP10342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/13/2018
• 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: 56 YR