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

Model Number	PLP11342
Medical Device Problem Codes	Material Fragmentation (1261); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
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.Device remains in the patient.
Event or Problem Description
As reported: "primary procedure, right first mtp.It was reported that when the drill guide was seated into a hole of the plate and after drilling was done, a thread-like piece of metal was seen in the patient.The piece was removed by the surgeon.Surgeon reported that it felt as though the drill guide did not seem to be seating as deeply in the hole as it had in the previous holes, and believes that the thread of metal was shaved off of the plate while drilling.Procedure was completed successfully with no delay.".

• Brand Name: PLATE ANCHORAGE MTP / VERSION V2 - RIGHT
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11229114
• Report Number: 0008031020-2021-00029
• Device Sequence Number: 3512951
• Product Code: HRS
• UDI-Device Identifier: 07613252260516
• UDI-Public: 07613252260516
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 01/26/2021

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: PLP11342
• Device Catalogue Number: PLP11342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR