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

Model Number 1896-4026S

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 12/03/2021

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 284970141
• Report Number: 0009610622-2021-00830
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202321
• UDI-Public: 04546540202321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 58 KG