MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 PROXIMAL LOCKING SCREW; IMPLANT

Catalog Number UNK_KIE

Device Problem Failure to Align (2522)

Patient Problems Failure of Implant (1924); Unequal Limb Length (4534); Implant Pain (4561)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

The customer reported that the patient presented with pain 6 weeks after implantation with a t2 nail.On x-ray it was noted that the screws had not gone through the nail.The surgeon checked the target device prior to the case and also after the case.The customer would like the jig to be inspected.New information and corrections received 27/05/2021.According to the adverse incident report: proximal displacement of nail.Patient underwent recon nailing of his right femur on (b)(6) 2021.There were no noticed complications during the procedure.Check x-ray was taken on (b)(6) 2021 no significant problem was identified.Patient reviewed at clinic on (b)(6) 2021.Check x-ray taken showed that there had been proximal displacement of the nail with some collapse and rotation at the fracture site.This was in keeping with the proximal locking screws not being through the nail (allowing proximal migration of the nail).The patient was also sent for an additional true lateral of the hip at that appointment.Patient examined and it was noted that the leg was approximately 2cm short with some slight external rotation of the foot.Patient has subsequently had revision surgery in rvh.

Event Description

The customer reported that the patient presented with pain 6 weeks after implantation with a t2 nail.On x-ray it was noted that the screws had not gone through the nail.The surgeon checked the target device prior to the case and also after the case.The customer would like the jig to be inspected.New information and corrections received 27/05/2021.According to the adverse incident report: proximal displacement of nail.Patient underwent recon nailing of his right femur on (b)(6) 2021.There were no noticed complications during the procedure.Check x-ray was taken on (b)(6) 2021 no significant problem was identified.Patient reviewed at clinic on (b)(6) 2021.Check x-ray taken showed that there had been proximal displacement of the nail with some collapse and rotation at the fracture site.This was in keeping with the proximal locking screws not being through the nail (allowing proximal migration of the nail).The patient was also sent for an additional true lateral of the hip at that appointment.Patient examined and it was noted that the leg was approximately 2cm short with some slight external rotation of the foot.Patient has subsequently had revision surgery in rvh.

Manufacturer Narrative

D9 / h3 updated to indicate device was not returned.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.In case the item and / or substantive information will become available in future the file will be reviewed and reopened.H3 other text : device disposition is unknown.

• Brand Name: UNKNOWN T2 PROXIMAL LOCKING SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11966707
• MDR Text Key: 255325947
• Report Number: 0009610622-2021-00545
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• 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
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability