MAUDE Adverse Event Report: STRYKER GMBH SCALED DRILL 2.5MM, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 703966

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation any additional information will be reported in a supplemental report.

Event Description

It was reported via medwatch #(b)(4): the patient was a trauma case with multiple injuries.During the repair of a fractured pelvis, 2 of the 2.5 mm drill bits, from the stryker pro system, fractured off during screw application, tips of the drill bits were left in the bone.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument.Always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way.Ensure that drilling and cutting tools are sharp.In the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.¿ 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.However, one of the probable causes of the drill tip breakage could be patient factor related i.E.Hard dense bone in young patient as per additional information provided.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported via medwatch #: (b)(4) : the patient was a trauma case with multiple injuries.During the repair of a fractured pelvis, 2 of the 2.5 mm drill bits, from the stryker pro system, fractured off during screw application, tips of the drill bits were left in the bone.

Event Description

It was reported via medwatch #(b)(4): the patient was a trauma case with multiple injuries.During the repair of a fractured pelvis, 2 of the 2.5 mm drill bits, from the stryker pro system, fractured off during screw application, tips of the drill bits were left in the bone.

Manufacturer Narrative

D9 / h3 update to indicate device was returned; h6 method, results, conclusion codes updated based on investigation results.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the tip of the drills is indeed broken.The surface of the breakage surface clearly indicate that excessive mechanical force had been applied during use.The bending of the drill while it rotates can indeed generate very high forces (due to the level arm) at the tip of the drill, leading to the reported breakage.The user must give extra precaution especially because of the length 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿ensure that you are familiar with the recommended uses, compatibility and correct handling of the instrument.Always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way.Ensure that drilling and cutting tools are sharp.In the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by application of excessive mechanical force and overbending the device during use.If any further information is provided, the investigation report will be reassessed.

• Brand Name: SCALED DRILL 2.5MM, AO FITTING
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11734921
• MDR Text Key: 252362469
• Report Number: 0008031020-2021-00189
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613252719861
• UDI-Public: 07613252719861
• 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,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 703966
• Device Catalogue Number: 703966
• Device Lot Number: KU121043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 109