MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE 95MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.295S

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot: manufacturing location: (b)(4), manufacturing date: 14-sep-2018, expiration date: 01-sep-2028, part number: 04.038.295s, tfna helical blade 95mm -sterile, lot number: h713604 (sterile), lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, ns065693 rev p met all inspection acceptance criteria packaging label log (pll) lmd rev ac was rdevice 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.Eviewed and determined to be conforming.Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.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 history review: 14-jun-2021: dhr reviewed by: (b)(4).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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery for subtrochanteric fracture of femur.The 95 mm blade was inserted which was short, and it was removed and replaced with a 105 mm blade.Procedure was completed successfully with thirty(30) minutes delay.This report is for one (1) tfna helical blade 95mm sterile.This is report 1 of 1 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.H10 additional narrative: g1: physical manufacturer updated.H4: manufacturing date updated.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 95MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12054186
• MDR Text Key: 268139235
• Report Number: 8030965-2021-05277
• 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
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.295S
• Device Lot Number: H713604
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/27/2021
• Supplement Dates FDA Received: 07/23/2021
• Patient Sequence Number: 1