MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 80MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.280S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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: aug 7, 2018.Expiration date: aug 1, 2028.Part number: 04.038.280s, tfna helical blade 80mm -sterile lot number: h691634 (sterile).Work order traveler met all inspection acceptance criteria apart.Inspection sheet, final inspection, (b)(4) rev p met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac was reviewed 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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿femoral fractures had occurred, and reoperation scheduled¿ does not indicate breakage of the blade.Therefore, review of the raw material would not be pertinent to the reported complaint condition.Device history review oct 10, 2020: dhr reviewed by: (b)(6).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) 2020, the patient underwent osteosynthesis surgery for femoral trochanteric fractures by using the tfna implants.The surgery was successfully completed with a more-than-30-minute delay, but it was not reported how many minutes it was delayed.It was confirmed on (b)(6) that femoral supracondylar fractures had occurred, and reoperation was done by using plate and cable on (b)(6) 2020.There is no further information available.This report is for one (1) tfna helical blade 80mm sterile.This is report 1 of 4 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 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 80MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10672190
• MDR Text Key: 213484607
• Report Number: 8030965-2020-07878
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652422
• UDI-Public: (01)07611819652422
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: H691634
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø12 125° L200 TIMO15
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 52