MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA FENESTRATED SCREW 95MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.195S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Unknown date in 2018.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.(b)(4).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 reports an event in (b)(6) as follows: it was reported that the patient underwent a revision surgery to fix a sub-trochanteric fracture on (b)(6) 2018.The patient's initial surgery was six months ago on an unknown date in 2018.In between three and six months post-op, the patient fell three times.After the third time, the patient started to feel pain in the hip.When the patient was checked in the hospital, x-ray showed that one (1) trochanteric femoral nailing system advanced (tfna) nail, and one (1) titanium (ti) tfna fenestrated screw were broken.The patient was revised with a new tfna nail and blade.The surgeon believes the breakage was due to the falls.There was no reported surgical delay.The procedure was completed successfully with the patient in stable condition.Concomitant device: distal locking screw (part# 04.005.530, lot# l723843, quantity# 1).This report is for one (1) tfna fenestrated screw 95mm - sterile.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: 04.038.195s, lot: h421510.Manufacturing location: elmira, manufacturing date: aug 18, 2017, expiry date: aug 01, 2027.A review of the device history record revealed no complaint related anomalies.This lot was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This 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.A review of the raw material device history record(s) determined the raw material lot h189268 met all specifications with no issues documented that would contribute to this complaint condition.Product investigation was completed.The returned tfna fenstrated screw 95mm (04.038.195s) was examined and found to be broken through the proximal-most fenestration hole.Additional surface wear consistent with implantation and explantation was noted which would not impact device functionality.The received condition of the device was found match the complaint description of broken, as such the complaint is confirmed.Based on the complaint description the patient had multiple post-operative falls which the surgeon felt contributed to the device failure, as such a root cause related to postoperative trauma was determined.Relevant drawing, reflecting the current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The device¿s raw material was reviewed as part of the device history records; the material met all specifications with no issues documented that would contribute to this complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The complaint is confirmed as the received fenestrated screw was found to be broken.Based on the complaint description the patient had multiple post-operative falls which the surgeon felt contributed to the device failure, as such a root cause related to postoperative trauma was determined.The system risk document was found to adequately address the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.

• Brand Name: TFNA FENESTRATED SCREW 95MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8169489
• MDR Text Key: 130504030
• Report Number: 8030965-2018-59085
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652323
• UDI-Public: (01)07611819652323
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.195S
• Device Lot Number: H421510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Date Manufacturer Received: 01/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR