MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, HUMERUS T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0143
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Nerve Damage (1979); Injury (2348); Fracture, Arm (2351)
Date of Event	05/15/2020
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
The doctor indicated that the "arch was crooked" and could not perform the surgical procedure correctly ("the screw was left out"), which extended the time of the surgery.Additionally reported by the user facility: "regarding the event that happened.I checked the instruments afterwards and it is not miscalibrated." additionally reported by company representative: "on june 26th we have been notified by the doctor that the patient was left with a brachial nerve damage.He said that this occurs in around 30 to 60% of patients who soft tissue is pulled, and this is why he preferred to use the nail to the plate.As he was not able to block well with the arch, the bone cracked, he had to open it and when trying to put cerclage, the nerve was pulled more than necessary and the patient was left with that result.The recovery of the patient is expected into 6 weeks to 6 months approximately.".
Event or Problem Description
The doctor indicated that the "arch was crooked" and could not perform the surgical procedure correctly ("the screw was left out"), which extended the time of the surgery.Additionally reported by the user facility: "regarding the event that happened.I checked the instruments afterwards and it is not miscalibrated." additionally reported by company representative: "on june 26th we have been notified by the doctor that the patient was left with a brachial nerve damage.He said that this occurs in around 30 to 60% of patients who soft tissue is pulled, and this is why he preferred to use the nail to the plate.As he was not able to block well with the arch, the bone cracked, he had to open it and when trying to put cerclage, the nerve was pulled more than necessary and the patient was left with that result.The recovery of the patient is expected into 6 weeks to 6 months approximately.".
Additional Manufacturer Narrative
Correction: refer to d4 lot number the alleged event was not confirmed.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product.The returned device was conforming to specifications and was fully functional.Potentially reduced accuracy in guidance is usually found during functional check (required per labelling).In case of any deviation it is realized prior to use.Preoperative testing is required in the labelling; maintaining measures during and after re-processing is also highlighted in the labelling.Although a root cause could not be determined the alleged event was classified having been caused by a suboptimal intra-operative procedure and was regarded being user related.In case other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a new root cause.

• Brand Name: TARGET DEVICE, HUMERUS 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: 10308255
• Report Number: 0009610622-2020-00367
• Device Sequence Number: 13654267
• Product Code: LXH
• UDI-Device Identifier: 04546540196071
• UDI-Public: 04546540196071
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 1806-0143
• Device Catalogue Number: 18060143
• Device Lot Number: KME913619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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