MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 80MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.180S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: (b)(6).Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent a total hip replacement procedure.The surgeon was successfully removed the tfna hardware with no adverse event.It was unknown if the surgery completed successfully.The patient status is unknown.This complaint involves two (2) devices.This report is for (1) tfna fenestrated screw 80mm - sterile.This report is 2 of 2 for (b)(4).
Additional 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: a1: patent identifier: (b)(6).H3, h6: investigation summary.Photo investigation.The device was not returned.A photo-investigation was performed on the images provided.Upon inspecting images provided in the email under notes & attachments section, there were no issues observed with the tfna fem nail ø11 r 130° l360 timo15 which contributes to the adverse event, hence unconfirmed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 can't be 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.Device history lot.Part number: 04.038m180sp.Lot number: 10l4581.Part manufacture date: 17-jun-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 fenstrated screw 80mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot was shipped out 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.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 80MM - 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: 12355469
• Report Number: 2939274-2021-04811
• Device Sequence Number: 3308656
• Product Code: HSB
• UDI-Device Identifier: 10886982098696
• UDI-Public: (01)10886982098696
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/27/2021

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: 04.038.180S
• Device Catalogue Number: 04.038.180S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA FEM NAIL Ø11 R 130° L360 TIMO15; TFNA FEM NAIL Ø11 R 130° L360 TIMO15
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR