MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE L95 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.295S

Device Problem Migration (4003)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(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 on (b)(6) 2019, the patient fell down from the fourth floor, and he fractured right femoral trochanter part.On (b)(6) 2019, the patient underwent osteosynthesis surgery with the tfna in question.The postoperative course was good.On (b)(6) 2019, the patient reported pain (the pain scale was six tenth).The patient had felt slight pain after the surgery.On (b)(6) 2019, the patient walked in the hospital, but he reported severe pain (the pain scale was eleven tenth).The hospital followed up the patient.On (b)(6) 2019, the hospital confirmed by x-rays that medial migration and non-union occurred, and the blade penetrated into pelvis.On (b)(6) 2019, the patient underwent removal surgery of tfna and tha surgery.The blade end extended maximally.There was no record that the patient fell down after the first surgery.The surgeon commented that he used pfna and tfna many times, but he didn¿t experience this event which is blade penetration into pelvis.The patient was alcoholism.No further information is available.Concomitant device reported: locking screw 5 l32 f/nails tan light green (part # 04.005.522s, lot # 3l74529, quantity # 1), tfna femoral nail ø10 130° l170 timo15 (part # 04.037.042s, lot# h783727, quantity # 1), tfna end cap extens.0 tan (part # 04.038.000s, lot # 3l89539, quantity # 1).This report is for one (1) tfna helical blade l95 tan.This is report 1 of 1 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.H3, h4, h6: the tfna helical blade was returned due to implant migration.No damage was noted aside from wear consistent with implantation and explantation.Grinding marks visible on the round part of the shaft.No abrasion marks visible on the flat surface.Replication of the implanted condition could not be performed at cq, however, the helical blade was able to pass through the returned nail's head element hole/aperture (04.037.042s; h783727) without any issue.No off-axis toggling was noted once the locking mechanism of the nail is advanced properly.Rotational and static locking of the blade could be achieved.The complaint condition of blade migration could be confirmed based on the provided x-rays.However, a replication of the implanted condition could not be performed during cq investigation; the helical blade was able to pass through the returned nail's head element hole/aperture (04.037.042s; h783727) without any issue.No off-axis toggling was noted once the locking mechanism of the nail is advanced properly.The review of the device history record revealed that this tfna blade was manufactured in april 2019 according to the specifications.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.No product related issues that would have contributed to the clinical finding of implant migration were found and we are not aware of any quality issues for this part and lot number combination.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.Further information / precaution hints can be found in the respective surgical technique (dsem/trm/0514/0052).Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot manufacturing location: elmira / monument, manufacturing date: 11-apr-2019, expiration date: 01-apr-2029, part number: 04.038.295s, tfna helical blade 95mm -sterile, lot number: h864977 (sterile).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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

Updated concomitant device reported: locking screw 5 l32 f/nails tan light green (part# 04.005.522s, lot# 3l74529, quantity#1), tfna end cap extens.0 tan (part# 04.038.000s, lot# 3l89539, quantity#1).

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.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 HELICAL BLADE L95 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9491151
• MDR Text Key: 185694774
• Report Number: 8030965-2019-71219
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652453
• UDI-Public: (01)07611819652453
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.295S
• Device Lot Number: H864977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/10/2020; 01/22/2020
• Supplement Dates FDA Received: 01/21/2020; 02/13/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø10 130° L170 TIMO15
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 58