MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL ROD T2 FEMUR 9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0110
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the customer called the sales rep during surgery and complained that none of the instruments on the metal extraction fit the proximal humeral nail.According to the doctor, he had already removed the transverse screws, but neither the extraction rod nor the 6mm conical adapter would grab the proximal end of the nail.All efforts on the part of the sales rep to provide a satisfactory solution were unsuccessful.Specifically, the problem was probably that the adapters always came loose when trying to drive the nail out.The sales rep suspected that the nail would rotate with it, since the transverse screws had already been removed - but according to the doctor, this was not the case.The sales rep received a picture of the contents of the me set after the surgery - all instruments were present." additional information: proximal humerus had to be split to loosen the nail.The surgery took 2 hours.According to the doctor, if the proper instruments were presented, the procedure would have been completed in about 30 to 45 minutes.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the returned universal rod and extraction rod could be assembled and engaged to a sample nail as intended.Due to missing counterpart [nail in question] a functional inspection in combination with the implant in question could not be performed.More detailed information about the complaint event as well as the affected nail must be available in order to determine the root cause of the complaint event.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.
Event or Problem Description
As reported: "the customer called the sales rep during surgery and complained that none of the instruments on the metal extraction fit the proximal humeral nail.According to the doctor, he had already removed the transverse screws, but neither the extraction rod nor the 6mm conical adapter would grab the proximal end of the nail.All efforts on the part of the sales rep to provide a satisfactory solution were unsuccessful.Specifically, the problem was probably that the adapters always came loose when trying to drive the nail out.The sales rep suspected that the nail would rotate with it, since the transverse screws had already been removed - but according to the doctor, this was not the case.The sales rep received a picture of the contents of the me set after the surgery - all instruments were present." additional information: proximal humerus had to be split to loosen the nail.The surgery took 2 hours.According to the doctor, if the proper instruments were presented, the procedure would have been completed in about 30 to 45 minutes.

• Brand Name: UNIVERSAL ROD T2 FEMUR 9 MM
• 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: 11787199
• Report Number: 0009610622-2021-00507
• Device Sequence Number: 1020681
• Product Code: LXH
• UDI-Device Identifier: 04546540196019
• UDI-Public: 04546540196019
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 1806-0110
• Device Catalogue Number: 18060110
• Device Lot Number: K680253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 70