MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER, SELF-HOLDING, LONG 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060233
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
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: "instrument cleanliness: a.An unknown pin ~3.2 x 290mm was found inside the opening reamer (2351-6113).It was completely embedded and jammed inside the reamer.The pin, along with the reamer lumen, were covered with dry blood/ tissue after manual removal in ssu.B.A long screwdriver 3.5mm (1806-0233) was inside the screwdriver sleeve (as a 2-part instrument).When the 2 parts were separated, the screwdriver shaft and the screwdriver sleeve's lumen were also covered with dry blood/ tissue.".
Event or Problem Description
As reported: "instrument cleanliness: a.An unknown pin ~3.2 x 290mm was found inside the opening reamer (2351-6113).It was completely embedded and jammed inside the reamer.The pin, along with the reamer lumen, were covered with dry blood/ tissue after manual removal in ssu.B.A long screwdriver 3.5mm (1806-0233) was inside the screwdriver sleeve (as a 2-part instrument).When the 2 parts were separated, the screwdriver shaft and the screwdriver sleeve's lumen were also covered with dry blood/ tissue.".
Additional Manufacturer Narrative
The reported event could be confirmed with the provided video evidence which matches the alleged failure.The device inspection revealed the following: during visual inspection, no traces of lumen / dry blood/ tissues were observed in the returned devices.This is most probably due to the decontamination of devices prior to visual inspection.But based on the provided videos the event could be confirmed as we can see a wire / pin stuck in the reamer and being taken out, also the screwdriver when taken out from sleeve is seen to be having biological contamination.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.Based on the investigation and product being part of the loaner kit, a local nc at the distribution end is opened to address the event and determine how the defective product escaped the inspection process at distribution facility.If more information is provided, the case will be reassessed.

• Brand Name: SCREWDRIVER, SELF-HOLDING, LONG 3.5 MM
• 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: 19435581
• Report Number: 0009610622-2024-00259
• Device Sequence Number: 12860414
• Product Code: LXH
• UDI-Device Identifier: 04546540520425
• UDI-Public: 04546540520425
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 18060233
• Device Lot Number: KMW352001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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