MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE L80 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.280S

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Revision surgery was planned for (b)(6) 2017; however it is unknown if the patient revised on (b)(6) 2017 and if the device was explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Medical safety officer reviewed x-rays and complaint description and stated that it appears that the cut-out is isolated to the blade, likely due to poor bone quality and progressive compression of femoral head.The remainder of the construct does not appear to have malfunctioned, nor contributed to the cut-out.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent the original surgery to treat the femoral trochanteric fracture on (b)(6) 2017.X-rays were taken during the healing period, three weeks through two months, after the initial surgery.After observations of the x-rays, it was confirmed that the reduction area had shifted.Cut-out was noticed three months after the surgery.An explant surgery is planned with total hip arthroplasty on (b)(6) 2017.Surgeon commented that the original reduction was the dissection type, which could have been attributable to the shift and the extramedullary type was ideal.Concomitant device reported: 12mm/125 deg ti cann tfna 170mm - sterile (part # 04.037.212s, lot # unknown, quantity 1), ti end cap for tfna 0mm extn - sterile (part # 04.038.000s, lot # unknown, quantity 1), 5.0mm ti locking screw w/t25 stardrive 32mm f/im nail-sterile (part # 04.005.522s, lot # unknown, quantity 1).This report is for one (1) tfna helical blade 80mm sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device history records review was completed for part# 04.038.280s, lot# h201009.Manufacturing location: (b)(4), manufacturing date: oct 05, 2016, expiry date: sep 01, 2026.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 80mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.This complaint is confirmed based on the review of received x-rays.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Updated concomitant devices: lot numbers added.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Concomitant devices reported: 12mm/125 deg ti cann tfna 170mm - sterile (part # 04.037.212s, lot # h027197, quantity 1), ti end cap for tfna 0mm extn - sterile (part # 04.038.000s, lot # l312285, quantity 1), 5.0mm ti locking screw w/t25 stardrive 32mm f/im nail-sterile (part # 04.005.522s, lot # l013988, quantity 1).

• Brand Name: TFNA HELICAL BLADE L80 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7200887
• MDR Text Key: 97577043
• Report Number: 8030965-2018-50432
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652422
• UDI-Public: (01)07611819652422(17)260901(10)H201009
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: H201009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/17/2018; 03/21/2018
• Supplement Dates FDA Received: 01/17/2018; 03/21/2018
• Date Device Manufactured: 10/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR