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

Catalog Number	705025
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported through medwatch " during orif procedure of comminuted tibia fracture, a screw bit was drilled within the proximal tibia and broke within the tibia.The surgeon kept the drill bit intact as removing it would cause more harm, as he would have had to remove the plates and screws, causing instability within the fracture.Intentionally retained fb disclosed to patient by surgeon".
Additional Manufacturer Narrative
The reported event that drill bit axsos 3 ti non-locking, short, ø2.5 x 216mm was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned (broken tip left insitu) for evaluation and no other evidences were provided despite multiple attempts.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.Nevertheless, note that a corrective nc # 1359091 has been already initiated in the past in order to address this occurrence.A review of the labeling did not indicate any abnormalities.No indications of a 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.H3: device was not returned.
Event or Problem Description
It was reported through medwatch " during orif procedure of comminuted tibia fracture, a screw bit was drilled within the proximal tibia and broke within the tibia.The surgeon kept the drill bit intact as removing it would cause more harm, as he would have had to remove the plates and screws, causing instability within the fracture.Intentionally retained fb disclosed to patient by surgeon".

• Brand Name: DRILL BIT AXSOS 3 TI NON-LOCKING, SHORT, Ø2.5 X 216MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7875039
• Report Number: 0008031020-2018-00604
• Device Sequence Number: 19352035
• Product Code: HRS
• UDI-Device Identifier: 07613327083422
• UDI-Public: 07613327083422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 705025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other