MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X180 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 1806-4270

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

The following was reported via medwatch (b)(4): a stryker drill bit broke and within the body of the medial calcaneus during the procedure.The drill bit was noted to be within the substance of the bone and was left in place.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.With the available information, it was observed that a t2 femur drill was used in an ankle surgery.The device is not intended to be used in ankle related surgery, hence this potentially a case of an off-label use if device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

The following was reported via medwatch (b)(4): a stryker drill bit broke and within the body of the medial calcaneus during the procedure.The drill bit was noted to be within the substance of the bone and was left in place.

• Brand Name: DRILL, AO T2 FEMUR Ø4,2X180 MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12601906
• MDR Text Key: 283413298
• Report Number: 0009610622-2021-00743
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 04546540196804
• UDI-Public: 04546540196804
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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
• Device Operator: Health Professional
• Device Model Number: 1806-4270
• Device Catalogue Number: 18064270
• Device Lot Number: K07AA83
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/09/2021
• Supplement Dates Manufacturer Received: 11/25/2021
• Supplement Dates FDA Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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
• Patient Age: 57 YR
• Patient Sex: Female