MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM; PLATE, FIXATION, BONE

Catalog Number 705025S

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that in treating a left medial tibial plateau fracture, two drill bits broke off in the patient.Surgeon did not remove the portion of the drill bits that were in the patient and did not report the rationale behind that decision to the rep.A surgical delay of 1-2 minutes was reported.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The reported event that drill bit axsos 3 ti non-locking, short, ø2.5 x 216mm was alleged of issue s-11 (breakage during surgery) 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.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.A review of the labeling did not indicate any abnormalities.The operative technique was reviewed and it gives detailed step to step guide for using the drill.It instructs that the ø2.5mm drill bit (ref (b)(4) should be used along with the drill guide (ref (b)(4) for proper guidance and drilling of the bone.If device is returned or any further information is provided, the investigation report will be reassessed.Device not received.

Event Description

It was reported that in treating a left medial tibial plateau fracture, two drill bits broke off in the patient.Surgeon did not remove the portion of the drill bits that were in the patient and did not report the rationale behind that decision to the rep.A surgical delay of 1-2 minutes was reported.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7040918
• MDR Text Key: 93084975
• Report Number: 0008031020-2017-00655
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

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: No Information
• Device Catalogue Number: 705025S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR