MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN PLATE; IMPLANT

Catalog Number UNK_SEL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "patient had an infection which led to the removal of all the plate and screws.We were doing a tibial plate removal of plate and screws at (b)(6) in (b)(6).One of screws were very tight and first couple of attempts of taking screws was unsuccessful.When the surgeon went to torque the driver, the tip of the screw driver snapped off.The crack piece was not retrieved it was thrown away at the facility.Procedure was completed successfully, used another screwdriver and it worked.No impact to the patient.Roughly a 30 sec- 1 minute delay.

Event Description

As reported: "patient had an infection which led to the removal of all the plate and screws.We were doing a tibial plate removal of plate and screws at (b)(6) hospital in (b)(6).One of screws were very tight and first couple of attempts of taking screws was unsuccessful.When the surgeon went to torque the driver, the tip of the screw driver snapped off.The crack piece was not retrieved it was thrown away at the facility.Procedure was completed successfully, used another screwdriver and it worked.No impact to the patient.Roughly a 30 sec- 1 minute delay.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: UNKNOWN PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11865489
• MDR Text Key: 252137043
• Report Number: 0008031020-2021-00231
• Device Sequence Number: 1
• Product Code: HRS
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR