MAUDE Adverse Event Report: STRYKER GMBH FREEHAND DRILL IMN INSTRUMENTS Ø4.2X130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23514213S
Medical Device Problem Codes	Break (1069); Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "when drilling for 2nd locking screw in most distal m/l hole a notable chatter could be heard.Following which the tip of the drill broke off where it tapers down and tip fragment was then situated on the medial side of the nail within the patient.Broken drill was removed and the decision was made to leave the tip fragment in situ.Second distal locking was then performed using the a/p hole and a new drill from the same lot with no issues.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the corrections to d4 lot #, d9/h3 and h6 component code.The reported event could be confirmed, but the reported product is required for the detailed investigation.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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "when drilling for 2nd locking screw in most distal m/l hole a notable chatter could be heard.Following which the tip of the drill broke off where it tapers down and tip fragment was then situated on the medial side of the nail within the patient.Broken drill was removed and the decision was made to leave the tip fragment in situ.Second distal locking was then performed using the a/p hole and a new drill from the same lot with no issues.".

• Brand Name: FREEHAND DRILL IMN INSTRUMENTS Ø4.2X130MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17584665
• Report Number: 0009610622-2023-00283
• Device Sequence Number: 20053700
• Product Code: LXH
• UDI-Device Identifier: 07613327350289
• UDI-Public: 07613327350289
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 23514213S
• Device Lot Number: KU152809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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: 23 YR
• Patient Sex: Male