MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12 TI CANN RETRO/ANTEGRADE FEM NL/360-S; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.652S
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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2021, the patient underwent for removal of titanium cannulated retro/antegrade femoral nail, titanium spiral blade and six (6) unknown locking screws in preparation for total knee arthroplasty.It was unknown if the removal surgery completed successfully.The patient outcome was unknown.This complaint involves eight (8) devices.This report is for (1) 12 ti cann retro/ antegrade fem nl/360-s.This report is 1 of 8 for (b)(4).
Event or Problem Description
It was reported that the removal procedure was completed successfully.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5.H6: photo investigation: the complaint device was not returned for investigation.A photo investigation was completed using the provided image.The x-ray was reviewed and there appears to be no issue with the device.The reason for removal was noted as a total knee arthroplasty and the complaint devices had no effect on this.Manufacturing record evaluation revealed no non-conformance that could have resulted in this issue.Since the device was not returned, an as-received condition could not be assessed, and a dimensional inspection was not completed.There was no need for document review as the device did not contribute to the complaint condition.Conclusion: the complaint cannot be confirmed on the device during photo 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: part # 04.013.652s.Synthes lot # 6191485.Supplier lot # n/a.Release to warehouse date: 07aug2009.Manufactures by: synthes monument.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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: 12 TI CANN RETRO/ANTEGRADE FEM NL/360-S
• 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: 12284397
• Report Number: 2939274-2021-04518
• Device Sequence Number: 2885780
• Product Code: HSB
• UDI-Device Identifier: 10886982088215
• UDI-Public: (01)10886982088215
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/08/2021

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: 04.013.652S
• Device Catalogue Number: 04.013.652S
• Device Lot Number: 6191485
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 08/16/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI SPIRAL BLD 70 FOR TI RETRO FEM NL-EX; UNK - SCREWS: 5.0 MM LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR