MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.185

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the surgeons had to remove a trochanteric fixation nail-advanced (tfna) system due to the broken proximal and distal screws.No further information is provided.During manufacturer's investigation of the returned devices it was identified that tfna fenestrated screw 85mm is broken.This device condition was evaluated and determined to be reportable on (b)(6) 2021.This report is for one (1) tfna fenestrated screw 85mm.This is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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, h6: investigation summary.Investigation flow: damage.Visual inspection: the tfna scr perf l85 tan (part #: 04.038.185, lot #: h869164) was received at us cq.Upon visual inspection, the threaded portion of the device has broken off and the broken fragments were returned.Nicks and scratches were also observed on both broken fragments.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage of the device.Document/specification review: no design issues or discrepancies were identified.The complaint was confirmed.Investigation conclusion: this complaint is confirmed as the threaded portion of the fenestrated screw has been broken off.Although no definitive root-cause can be determined it is likely the device encountered unintended forces during use.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 ¿ packaged, labeled and released by: monument.Manufacturing date: apr 18, 2019.Expiration date: apr 01, 2029.Part number: 04.038.185s, tfna fenestrated screw 85mm -sterile.Lot number: h869164 (sterile).Lot quantity: 48.Work order traveler met all inspection acceptance criteria.Elmira inspection sheets, ns072828, met all inspection acceptance criteria.Inspection sheet, final inspection, ns065692 met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.And scn 16221 was not located for review however, the lot would not have been released if it did not meet sterility requirements.This lot met all dimensional, visual and packaging requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review.(b)(6) 2021: dhr reviewed.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 85MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11485874
• MDR Text Key: 250358399
• Report Number: 8030965-2021-01959
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819659728
• UDI-Public: (01)07611819659728
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.185
• Device Lot Number: H869164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Date Manufacturer Received: 03/15/2021
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L42 F/NAILS TAN LIGHT GREEN.; LOCKSCR Ø5 L52 F/NAILS TAN LIGHT GREEN.; TFNA FEM NAIL Ø9 LE 130° L380 TIMO15.
• Patient Outcome(s): Required Intervention