MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X26 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-4026S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported that after surgery of the t2 humeral nail, the most proximal and most distal screws have backed out.Revision surgery is planned at (b)(6) 2021.Update 12/17/2021: revision surgery was performed on (b)(6) 2021.
Additional Manufacturer Narrative
The reported event could be confirmed, since images available presents screw migration.A physical device inspection was not possible since the affected device was not returned and thus, limited to details available.A pptx file with a sequence of x-ray images was provided and forwarded to hcp for comments [excerpts]: the rotational forces acting due to the lack of reduction acted on the screws and led to the back out.Technically suboptimal performed with somewhat unfavorable fracture parameters.Based on above the root cause was attributed to a user related issue.The failure was caused by rotational forces resulting from a lack of fracture reduction.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.Ifu points out as following: ¿adverse effects in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: delayed union or non-union of the fracture site.These devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient's activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.Improper alignment can cause a mal-union of the bone and/or bending, cracking or even breakage of the device.¿ in case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
It was reported that after surgery of the t2 humeral nail, the most proximal and most distal screws have backed out.Revision surgery is planned on (b)(6) 2021.Update 12/17/2021.Revision surgery was performed on (b)(6) 2021.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 HUMERUS Ø4X26 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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13102209
• Report Number: 0009610622-2021-00830
• Device Sequence Number: 11685864
• Product Code: HSB
• UDI-Device Identifier: 04546540202321
• UDI-Public: 04546540202321
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2022

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: Lay User/Patient
• Device Expiration Date: 03/31/2026
• Device Model Number: 1896-4026S
• Device Catalogue Number: 18964026S
• Device Lot Number: K0ABEB0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 58 KG