MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC STD 125MM 5 CBL TROCH GRIP; CERCLAGE, FIXATION

Catalog Number	71340011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient who had intertan operation on (b)(6) 2017 at this hospital had pain and took x-ray at other hospital, then it was noted that the nail was broken.Revision surgery (bhr) wil be performed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual devices involved our investigation cannot proceed.If the devices or new information is received in the future, the complaints can be re opened.The clinical medical investigation concluded this case reports a ¿revision surgery (bhr) will be performed, but this has already been revised to a femoral stem with a tandem bipolar head and not a bhr implant due to a broken intertan nail.Four x ray photos where provided which demonstrate the intertrochanteric fracture and repair with cerclage wires and intramedullary nail and a femoral fracture plate and a broken nail with a non union of the intertrochanteric fracture, repaired with a femoral stem and bipolar head and cerclage wiring one x ray photo confirms the presence of the broken nail.There are no additional medical documents available for review and without the return of the associated device a product evaluation could not be included in this investigation.Additionally, there is no report of the patient¿s current condition following the revision.However, it is likely the patient will experience pain and possibly have post op rehab.In the absence of any relevant supporting documentation or the explant for analysis, a definitive root cause of the reported broken intertan nail cannot be determined but the nonunion of the femoral fracture is the likely root cause.Based on insufficient information, no further clinical assessment can be performed.Should additional information be provided, the clinical/medical investigation can be re evaluated at that time.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.Will proceed with a medical assessment based on clinical supporting documents provided.If no relevant medical information is provided can close the mi task.Approved by (b)(6), md a review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information.Surgical procedure/post-operative care review.Device labeling (including technique guides, ifus, etc.) this case reports a ¿revision surgery (bhr) will be performed¿ but this has already been revised to a femoral stem with a tandem bipolar head and not a bhr implant due to a broken intertan nail.Four x-ray photos where provided which demonstrate the intertrochanteric fracture and repair with cerclage wires and intramedullary nail and a femoral fracture plate and a broken nail with a non-union of the intertrochanteric fracture, repaired with a femoral stem and bipolar head and cerclage wiring one x-ray photo confirms the presence of the broken nail.There are no additional medical documents available for review and without the return of the associated device a product evaluation could not be included in this investigation.Additionally, there is no report of the patient¿s current condition following the revision.However, it is likely the patient will experience pain and have possibly have post op rehab.In the absence of any relevant supporting documentation or the explant for analysis, a definitive root cause of the reported broken intertan nail cannot be determined but the nonunion of the femoral fracture is the likely root cause.Based on insufficient information, no further clinical assessment can be performed.Should additional information be provided, the clinical/medical investigation can be re-evaluated at that time.Approved by (b)(6), md on (b)(6) 2019.

• Brand Name: ACC STD 125MM 5 CBL TROCH GRIP
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8329903
• Report Number: 1020279-2019-00533
• Device Sequence Number: 2229450
• Product Code: JDQ
• UDI-Device Identifier: 03596010485809
• UDI-Public: 03596010485809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71340011
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 06/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention