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

Model Number	1806-0113
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the event occurred during proximal upper arm fracture intramedullary nail removal.When removing the nail which was implanted about 2 years ago, the threaded part of the universal rod was broken and the nail could not be removed.The tip of the remover (probably the universal rod) stuck with the nail and closed with the tip left on the nail, as they could not be removed.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the returned universal rod shows traces of a frequent and intense use identified by the general appearance of the surfaces.Scratches are visible on the distal surface of the rod.The universal rod found to be broken from threaded portion.The breakage surface shows a brittle fracture.Plastic deformation along the breakage surface was not found.The outer end face of the handle is completely covered with significant hitting marks.A review of the device history for the reported lot did not indicate any abnormalities.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The fracture was most likely caused due to heavy impacts made on the device to extract the nail, leading to a sudden brittle fracture.Note that this device is subjected to external impacts, which fall under its intended use, hence a weakened structural integrity due to frequent use is plausible.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the event occurred during proximal upper arm fracture intramedullary nail removal.When removing the nail which was implanted about 2 years ago, the threaded part of the universal rod was broken and the nail could not be removed.The tip of the remover (probably the universal rod) stuck with the nail and closed with the tip left on the nail, as they could not be removed.".

• Brand Name: UNIVERSAL ROD, SHORT T2 HUMERUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11655842
• Report Number: 0009610622-2021-00440
• Device Sequence Number: 19707557
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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 Model Number: 1806-0113
• Device Catalogue Number: 18060113
• Device Lot Number: K145790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR