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

Model Number PLP11342

Device Problems Material Fragmentation (1261); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

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 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
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11229114
• MDR Text Key: 232523589
• Report Number: 0008031020-2021-00029
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613252260516
• UDI-Public: 07613252260516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLP11342
• Device Catalogue Number: PLP11342
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR