MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.395
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #(b)(4).Part returned.(b)(4).Investigation summary: background: it was reported that on (b)(6) 2021, the patient underwent a hardware removal of the trochanteric fixation nail advanced from the patient's right hip.Based on x-rays it was determined the helical blade was cutting through the femoral head.The patient's intertrochanteric fracture was healed.The original implant was on (b)(6) 2020.The hardware removal was successfully completed without delay.No patient consequence.This complaint involves three (3) devices.Manufacturing location: elmira/ packaged, sterilized and released by: (b)(4).Manufacturing date: 29-jan-2020.Expiration date: 31-dec-2029.Part number: 04.038.395s, tfna fenestrated helical blade 95mm -sterile.Lot number: 38p2009 (sterile).Lot quantity: (b)(4).Note: helical blade was manufactured by elmira; lot number 35p9372.Parts were packaged, sterilized and released by (b)(4).Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lppf rev g, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all 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 batch null, device history review 25-mar-2021: dhr reviewed.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Investigation flow: device interaction/functional.Visual inspection: the tfna fenestrated helical blade 95mm (part #: 04.038.395, lot #: 35p9372) was received at us cq.Visual inspection of the complaint device showed nicks and scratches.No other defect was detected.Functional test: replication of the implanted condition could not be performed at cq, however, the helical blade was able to pass through the returned nail's (part #: 04.037.142s, lot #: h808421) head element hole/aperture without issue.No off-axis toggling was noted.The complaint can't be replicated with the returned device.Document/specification review: 04_038_370 rev.C (current and manufactured) was reviewed.No design issues or discrepancies were identified.Complaint not confirmed investigation conclusion: this complaint is not confirmed as there were only nicks and scratches the returned device.These defects could be due to the implantation and explanation of the device.Moreover the device was able to pass through the returned nail's (part #: 04.037.142s, lot #: h808421) head element hole/aperture without issue.As no x-ray was provided showing the migration/back out/pull-out of the device, this complaint cannot be confirmed.No root cause could definitively be determined for the reported complaint condition.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 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 or Problem Description
It was reported that on (b)(6) 2021, the patient underwent a hardware removal of the trochanteric fixation nail advanced from the patient's right hip.Based on xrays it was determined the helical blade was cutting through the femoral head.The patient's intertrochanteric fracture was healed.The original implant was on (b)(6) 2020.The hardware removal was successfully completed without delay.No patient consequence.This complaint involves three (3) devices.This report is for one (1) tfna fenestrated helical blade 95mm.This report is 2 of 3 for (b)(4).
Additional 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 FENESTRATED HELICAL BLADE 95MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11670528
• Report Number: 2939274-2021-01843
• Device Sequence Number: 17018265
• Product Code: HSB
• UDI-Device Identifier: 10886982099266
• UDI-Public: (01)10886982099266
• Combination Product (Y/N): N
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.038.395
• Device Catalogue Number: 04.038.395
• Device Lot Number: 35P9372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11/130 DEG TI CANN TFNA 170 - STERILE; 5.0 TI LCKNG SCREW T25 SD 34 F/IM NAIL-S; TFNA FENESTRATED HELICAL BLADE 95 - SILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR