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

Catalog Number 04.038.280S

Device Problem Device-Device Incompatibility (2919)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 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 an open reduction internal fixation (orif) surgery for the femoral trochanteric fracture.During the impaction of the trochanteric fixation nail-advanced (tfna) blade, surgeon felt resistance and the operation was stopped.The implants were at a position where there was no problem.The surgeon stated that it was very hard when he knocked it in again.Surgeon tapped the blade to the end and since it was over-inserted, the surgeon finally decided to remove implants.Surgeon tried removal by connecting the extractor to the bottom of the inserter and felt the great resistance again.Upon close observation, surgeon found that the blade just moved back and forth at the crevice that allows sliding, and it did not move any further.It was revealed that the locking mechanism was lowered to the level of the blade hole of the tfna nail by the nurse.Finally the tfna blade and nail were removed successfully and procedure was completed by using new size implants.There was a surgical delay of ninety (90) minutes.There were health injuries such as prolongation of anesthesia time, additional invasion of soft tissue, femoral neck and bone head.Surgeon commented that it was possible that the blade had some defect because the same inserter could be used successfully when a new blade was inserted.No further information is available.Concomitant device reported: insertion instrument (part# unknown; lot# unknown; quantity:1); tfna fem nail ø9 125° l170 timo15 (part # 04.037.912s, lot # 16l9288, quantity 1) this report is for one (1) tfna helical blade 80mm sterile this is report 2 of 2 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.The product was returned to us cq for evaluation.The us cq conducted a visual inspection and functional testing of the returned device.Visual analysis of the returned sample revealed that the blade implant has heavy stress marks on the outer surface and helix cutting edges were severely nicked.The anodized layer is not present anymore at all damages, which indicates that they were caused post-manufacturing.The complete functional testing cannot be completed as all devices were not returned.The blade implant component insertion in the nail implant blade slot was not smooth may be due to the burr inside the nail slot and damaged helical blade.The dimensional inspection was not performed due to the post-manufacturing damage.The definitive cause for the observed device damage condition could not be identified.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed severe nicked condition of the helical blade implant blade would contribute to the complained device interaction issue.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 feb 17, 2021.Part number: 04.038m280sp, lot number: 21p0081, part manufacture date: 18-oct 18, 2019, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 80mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot was shipped to monument and assigned as part number 04.038.280s for final packaging.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material 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.Reviewed: mar 22, 2021.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.

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.H10 additional narrative: h3, h6: the device was 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.

• Brand Name: TFNA HELICAL BLADE 80MM STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11345831
• MDR Text Key: 239822848
• Report Number: 8030965-2021-01136
• 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,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.280S
• Device Lot Number: 21P0081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/23/2021
• Patient Sequence Number: 1
• Treatment: TFNA FEM NAIL Ø9 125° L170 TIMO15; UNK - INSERTION INSTRUMENTS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR