MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.205S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: ktt.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 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 patient underwent a hardware removal and total hip surgery due to non-union.The patient had a trochanteric fixation nail advanced (tfna) done in (b)(6) 2020.The patient voiced to surgeon that his previous surgeon stated it was a hardware failure and that is why he failed to heal.The surgeon doing surgery on (b)(6) 2021 stated it was not a hardware failure and it was because of his bone.This report is for one (1) tfna fenestrated screw 105mm - sterile.This is report 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.H10 additional narrative: h6: photo investigation: the device was not returned.A photo-investigation was performed.Upon inspecting the images provided, no defect is observed.Thus, the reported complaint condition is not confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition is not confirmed during photo/video investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.H6: a device history record (dhr) review was conducted: manufacturing location: elmira / monument, manufacturing date: 15-oct-2018, expiration date: 30-sep-2028.Part number: 04.038.205s, tfna fenestrated screw 105mm -sterile, lot number: h739928 (sterile) lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Scn 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.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.

• Brand Name: TFNA FENESTRATED SCREW 105MM - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11475398
• Report Number: 2939274-2021-01301
• Device Sequence Number: 17190887
• Product Code: HSB
• UDI-Device Identifier: 10886982098795
• UDI-Public: 10886982098795
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 02/15/2021

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: 04.038.205S
• Device Catalogue Number: 04.038.205S
• Device Lot Number: H739928
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 04/14/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 89