MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE BUSH ANCHORAGE 2.0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	XVIMQ001020
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Advance (2920)
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
Upon completion of investigation, additional information will be provided in a supplemental report.
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.".
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.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device was returned.The visual inspection showed that the part seems to be extensively used.All the laser marking is fading.The lot number is no more identifiable.Therefore, the traceability of this affected lot cannot be performed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL GUIDE BUSH ANCHORAGE 2.0MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11229117
• Report Number: 0008031020-2021-00030
• Device Sequence Number: 3512952
• Product Code: LXH
• UDI-Device Identifier: 07613252267027
• UDI-Public: 07613252267027
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 05/28/2021

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: XVIMQ001020
• Device Catalogue Number: XVIMQ001020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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