MAUDE Adverse Event Report: STRYKER GMBH FREEHAND DRILL IMN INSTRUMENTS Ø4.2X130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 23514213S

Device Problems Off-Label Use (1494); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "the service&repair center in the netherlands reported a stryker drill bit found stuck in a depuy synthes attachment.The attachment isn't working properly; the customer didn't provide further information.¿.

Manufacturer Narrative

The reported event could not be confirmed since the device was returned and found to be fully functional.Device inspection revealed the following: the received drill was visually inspected which shows clear deformation though out the drill cutting edges and tip have become blunt in nature, and the locking section is having material chipped off and bent inward which indicates forceful locking of the device.A functional test was performed with the sample drill machine in which we didn¿t find any issue in the assembly and disassembly of the device.A review of the device history for the reported lot did not indicate any abnormalities.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.Based on the investigation, the root cause was attributed to being an off-label use as the component was used with another manufacturer component, which is confirmed from the available pictures.If any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "the service&repair center in the netherlands reported a stryker drill bit found stuck in a depuy synthes attachment.The attachment isn't working properly; the customer didn't provide further information.¿.

• Brand Name: FREEHAND DRILL IMN INSTRUMENTS Ø4.2X130MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17470516
• MDR Text Key: 320508066
• Report Number: 0009610622-2023-00273
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327350289
• UDI-Public: 07613327350289
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 23514213S
• Device Lot Number: KU151070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1