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

Model Number	1806-0113
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "universal rod broke at the connection when extracting a t2 humeral nail that was inserted about 10 years ago.Because a new fracture occurred distal to the nail, it was decided to treat with a plate, and the nail was extracted this time.The nail could not be removed due to breakage of the universal rod, so another attempt is made to remove the nail on the (b)(6) 2022.".
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "universal rod broke at the connection when extracting a t2 humeral nail that was inserted about 10 years ago.Because a new fracture occurred distal to the nail, it was decided to treat with a plate, and the nail was extracted this time.The nail could not be removed due to breakage of the universal rod, so another attempt is made to remove the nail on the (b)(6) 2022.".
Additional Manufacturer Narrative
Please note corrections to d9/h3 and h6 method code as the device was returned for evaluation.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: 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 towards a brittle fracture due to a sudden impact load.The outer end face of the handle has dents indicating extensive hitting.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, 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 nature of breakage indicates towards a brittle fracture caused most likely caused due to high impact forces during nail extraction.If any additional information is provided, the investigation will be reassessed.

• 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
• 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: 14116135
• Report Number: 0009610622-2022-00138
• Device Sequence Number: 4335065
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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 Model Number: 1806-0113
• Device Catalogue Number: 18060113
• Device Lot Number: K730100
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2003
• 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 Sex: Unknown