MAUDE Adverse Event Report: STRYKER GMBH DRILL GUIDE 3.5MM INDEP. LAG SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	703686
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that drill has been 'welded' into the drill guide resulting in the drill to break during drilling.Surgeon said there was burning bone as a result and so used saline to cool it down.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The customer reported that drill has been 'welded' into the drill guide resulting in the drill to break during drilling.Surgeon said there was burning bone as a result and so used saline to cool it down.
Additional Manufacturer Narrative
Please note correction to h6 results code.The received pictures were reviewed.It can be confirmed that the fragment of the broken 2.6mm drill bit is stuck in the 2.6mm sleeve of the drill guide.The dark discolorations at both devices indicate that there was heat generated, most likely by friction between the drill bit and the guide.The affected devices were not returned for evaluation, therefore no further investigation is possible.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 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.No indications of material, manufacturing or 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.

• Brand Name: DRILL GUIDE 3.5MM INDEP. LAG SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12802402
• Report Number: 0008031020-2021-00463
• Device Sequence Number: 11919592
• Product Code: LXH
• UDI-Device Identifier: 07613327069822
• UDI-Public: 07613327069822
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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 Model Number: 703686
• Device Catalogue Number: 703686
• Device Lot Number: 1000310755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female