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

Model Number XVIMQ001020

Device Problems Difficult or Delayed Positioning (1157); Difficult to Advance (2920)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

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.".

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.".

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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11229117
• MDR Text Key: 232524264
• Report Number: 0008031020-2021-00030
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613252267027
• UDI-Public: 07613252267027
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

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: 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
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR