MAUDE Adverse Event Report: STRYKER GMBH SCALED DRILL Ø2.5MM, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703966
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2023
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
As reported: "during placement of a plate on a pelvic fracture, the two drill bits of the ancillary broke off one after the other and became stuck in the patient's bone.There was no possibility of removing them.Patient's current condition: the distal part of the drill bits remained in place in the pelvis.No clinical consequences observed.".
Event or Problem Description
As reported: "during placement of a plate on a pelvic fracture, the two drill bits of the ancillary broke off one after the other and became stuck in the patient's bone.There was no possibility of removing them.Patient's current condition: the distal part of the drill bits remained in place in the pelvis.No clinical consequences observed.".
Additional Manufacturer Narrative
Please disregard mfr report # 0008031020-2023-00401.Please note that this event is duplicate of stryker report mfr.Report # 0008031020-2023-00390 stryker pi (b)(4).

• Brand Name: SCALED DRILL Ø2.5MM, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18140159
• Report Number: 0008031020-2023-00401
• Device Sequence Number: 15100026
• Product Code: LXH
• UDI-Device Identifier: 07613252719861
• UDI-Public: 07613252719861
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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: 703966
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown