MAUDE Adverse Event Report: STRYKER GMBH UNIVERSAL ROD, SHORT T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060113
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/02/2024
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: "during nail removal, the tip of the universal rod was broken, and the tip of the universal rod became filled in the proximal portion of the nail, making removal impossible.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged failure.The returned universal rod shows signs of intense use evident by the appearance of scratches and minor dents all over the surface of the rod.The tip of the rod was found to be broken.The nature of the breakage indicates a brittle fracture due to a sudden impact load.The outer end face of the handle has dents indicating hitting.Furthermore, a hardness test according to rockwell was done at the time of manufacturing, which was reviewed in device history which indicates the material being by the values in the material specification.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, the root cause was attributed to being user related which was caused by excessive torsional and axial load.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "during nail removal, the tip of the universal rod was broken, and the tip of the universal rod became filled in the proximal portion of the nail, making removal impossible.".

• Brand Name: UNIVERSAL ROD, SHORT T2
• 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: 18811044
• Report Number: 0009610622-2024-00090
• Device Sequence Number: 16975497
• Product Code: LXH
• UDI-Device Identifier: 04546540196026
• UDI-Public: 04546540196026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: 18060113
• Device Lot Number: K0F2BE6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2018
• 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: 31 YR
• Patient Sex: Male