MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 HUMERUS 4X28 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-4028S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/20/2020
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
As reported: "the indication was left upper arm bone fracture.After the initial operation(performed on (b)(6) 2020), on (b)(6) 2020, during clinical observation the back out of the screw was found out in x-rays.It is judged that the bone union has not been achieved and the union was poor.So, the screw was removed and reinserted with another screw on the same date.The procedure completed without problem.".
Additional Manufacturer Narrative
The reported event was not confirmed.No evidence like x-rays or medical records was available to prove the event.Review of device history, labelling, 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(s).No indications of material, manufacturing or design related problems were found during the document review.The last 3 windings of the thread were nearly undamaged, followed by 6 or 7 windings significantly flattened.The remaining windings towards the head appeared also being undamaged.Implant migration is a known but rare event and has been considered in several publications.Screw migration can be contributed by (but not limited to) e.G.Patient¿s condition, choice of product, kind of treatment, patient¿s behavior and others.Based on available information it could not be determined which reasons had caused the event.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.
Event or Problem Description
As reported: "the indication was left upper arm bone fracture.After the initial operation(performed on (b)(6) 2020).On (b)(6) 2020, during clinical observation the back out of the screw was found out in x-rays.It is judged that the bone union has not been achieved and the union was poor.So, the screw was removed and reinserted with another screw on the same date.The procedure completed without problem.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 HUMERUS 4X28 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11060344
• Report Number: 0009610622-2020-01035
• Device Sequence Number: 2875791
• Product Code: HSB
• UDI-Device Identifier: 04546540202338
• UDI-Public: 04546540202338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: Lay User/Patient
• Device Expiration Date: 03/31/2025
• Device Model Number: 1896-4028S
• Device Catalogue Number: 18964028S
• Device Lot Number: K071AB3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 04/02/2021
• 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: 70 YR