MAUDE Adverse Event Report: STRYKER GMBH CANNULATED DRILL ASNIS III Ø4.9MM FOR SCREWS Ø6.5MM LARGE AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702601
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported by the patient's attorney as a result of a legal claim that allegedly on or about (b)(6) 2023, the patient had laparoscopic surgery to repair a pelvic fracture using a stryker drill and stryker 6.5 canula.Allegedly during the surgery, while using a stryker drill and putting hardware and screws, the surgeon noticed that black sludge was coming out of the stryker drill.It is alleged on (b)(6) 2023, the patient had drainage and puss from the incision site and was told she had an infection.On (b)(6) 2023, the patient underwent a ct scan that revealed an infection and a foreign material in her pelvic region.On (b)(6) 2023, the patient underwent a second surgery to remove a loose screw that had been left in her pelvis.(covered by another pi).

• Brand Name: CANNULATED DRILL ASNIS III Ø4.9MM FOR SCREWS Ø6.5MM LARGE 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: 17941774
• Report Number: 0008031020-2023-00362
• Device Sequence Number: 14192386
• Product Code: LXH
• UDI-Device Identifier: 04546540112767
• UDI-Public: 04546540112767
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 702601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female