MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE T2 RECON; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1806-3100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Failure of Implant (1924); Unequal Limb Length (4534); Implant Pain (4561)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem 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 (b)(6) 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.
Additional 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.According to event description ¿the surgeon checked the target device prior to the case and also after the case¿ and no deviation was reported.However, 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 was not returned.
Event or Problem 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.
Additional Manufacturer Narrative
Corrections - please refer to: h6 method, results and conclusion codes d9 / h3 updated as device was returned.B1/b2/h1 corrected.The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the device returned passed the pre-operative function test as intended.The alleged mis-targeting could not be reproduced.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation it is realized prior to use.According to event description ¿the surgeon checked the target device prior to the case and also after the case¿ and no deviation was reported.Although a definitive root cause could not be determined, the alleged event is most likely caused due to a suboptimal intra-operative procedure and has to be classified as user-customer-user error.No corrective actions are required at this time.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem 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 2 cm short with some slight external rotation of the foot.Patient has subsequently had revision surgery in rvh.

• Brand Name: TARGET DEVICE T2 RECON
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11966698
• Report Number: 0009610622-2021-00546
• Device Sequence Number: 16487511
• Product Code: HSB
• UDI-Device Identifier: 04546540654939
• UDI-Public: 04546540654939
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022

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: Health Professional
• Device Model Number: 1806-3100
• Device Catalogue Number: 18063100
• Device Lot Number: KME904060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 12/16/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/21/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown