MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT, AO DIA2.0MM X 135MM, SCALED; PLATE, FIXATION, BONE

Model Number 703690

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device remains in patient.

Event Description

As reported: "the drill ref 703690 broke during medical procedure.The part was left into patient body.Patient returned to hospital requesting the possibility to undergo mri with the drill inside a body.".

Manufacturer Narrative

The reported event could be confirmed, as although the device was not returned for evaluation, x-rays were sent to us as evidence of implant breakage.The device inspection was not possible since the affected device was not returned.An expert medical opinion was requested for the x-rays received, but due to the lack of information on the situation, it is difficult to assess the relevance of the case processed by the surgeon."the x-ray does not only show the plate and the screw in the intermetatarsal and the tarsometatarsal joint, there is also a fracture in healing of the third metatarsal and something happened in the proximal phalanx of the hallux.It seems as if the plate is positioned where it is intended to be and the screws are positioned correctly as well.[¿] regarding the mri, a potential problem is very unlikely, however, heating could occur, but that is more likely to be associated with the other material in the body and not with the small part of the drill bit.Under normal circumstances there are no other risks associated with the broken drill bit." a review of the device history for the reported lot did not indicate any abnormalities.No deviation from the specifications was noted.No indications of material, manufacturing or design related problems were found during the investigation.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 in order to determine the root cause of the complaint event.However, in general few of the probable causes of drill bit breakage are either material fatigue with load over a longer period of time or one-time load clearly above the limit of possible load based on the medical expert's opinion.If more information is provided, the case will be reassessed.

Event Description

As reported: "the drill ref 703690 broke during medical procedure.The part was left into patient body.Patient returned to hospital requesting the possibility to undergo mri with the drill inside a body.".

• Brand Name: DRILL BIT, AO DIA2.0MM X 135MM, SCALED
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15059949
• MDR Text Key: 302335483
• Report Number: 0008031020-2022-00340
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327069853
• UDI-Public: 07613327069853
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K170727
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 703690
• Device Catalogue Number: 703690
• Device Lot Number: 6000085074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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