MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ALPHA FEMUR NAIL, SIZE 9X300; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned at this time.If additional information becomes available, it will be provided in a supplemental report.Device retained by hospital.

Event Description

It was reported that the nail was implanted in (b)(6) 2021 to repair a femur fracture that never healed properly (non-union).The nail was inserted with an antibiotic coating.The patient returned for a scheduled revision.The planned revision was for the nail to be removed and a knee joint fused with arthrodesis nail.Once in the or, it was discovered the nail was broken.The surgeon changed his plan wen the broken nail was noticed.The broken nail was removed; a larger t2 alpha nail and titanium plate were put in.

Manufacturer Narrative

D2b and d2a, d3, d4 corrected.Please note: fda registration number should be (b)(6) the reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Nail breakage in general has been experienced but does not present an unanticipated event in itself.Depending on load application, also, depending on the patient¿s post implant behaviour and depending on suitable anatomical reduction, depending on the kind of bone breakage, depending on the course of bone healing and other factors ¿ e.G.Increased postoperative activities ¿ a nail breakage can rather be classified as anticipated; specifically if one or more contributing issues concurrence with each other.Initially ¿¿the nail was put in 2 months ago to fix a femur fracture that never healed properly.A non-union¿¿ and thus, it could not be excluded that the case is rather clinical conditions related.According to event description ¿¿the doctor's initial plan for the knee fusion was changed once we noticed that the nail was broken.¿¿ and finally, the broken nail was revised by a ¿larger t-2 alpha nail and titanium plate¿ which could be considered as a hint to insufficient bone healing.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects are clearly pointed out in the labelling.Nevertheless, more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.An indication of material, manufacturing or design related problems could not be checked as the device was not made available for a physical evaluation.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 the nail was implanted in (b)(6) 2021 to repair a femur fracture that never healed properly (non-union).The nail was inserted with an antibiotic coating.The patient returned for a scheduled revision.The planned revision was for the nail to be removed and a knee joint fused with arthrodesis nail.Once in the or, it was discovered the nail was broken.The surgeon changed his plan when the broken nail was noticed.The broken nail was removed; a larger t2 alpha nail and titanium plate were put in.

• Brand Name: UNKNOWN T2 ALPHA FEMUR NAIL, SIZE 9X300
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12301985
• MDR Text Key: 265861987
• Report Number: 0008031020-2021-00347
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White