MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.008.216S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Unknown event date.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 Description

It was reported that on an unknown date, patient underwent a removal of hindfoot nail(1), two (2) unknown screws: 6.0mm, two(2) unknown screws: 5.0mm and two(2) unknown screws: 4.5mm for unknown reason.It was unknown how the procedure was completed.Patient's outcome was unknown.Concomitant device reported: unk screws: foot (6.0mm) (part# unknown; lot# unknown; quantity: 2).Unk screws: foot (5.0mm) (part# unknown; lot# unknown; quantity: 2) unk screws: 4.5 mm cannulated (part# unknown; lot# unknown; quantity: 2).This is report 1 of 1 for (b)(4).This report is for a hindfoot nail.

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, h4, h6 investigation summary.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that there was no damage or defects with the 12 ti hindfoot arthro cann nl 180/rt-s.In addition, the screw does not seem to sit flush with the bone but it cannot be determined if the screw had migrated postoperatively.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for 12 ti hindfoot arthro cann nl 180/rt-s.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: part #: 04.008.216s , synthes lot #: h490998, supplier lot #: n/a , release to warehouse date: 10 nov 2017, manufactured by: monument, supplier: n/a.No ncr's 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: 12MM TI HINDFOOT ARTHRODESIS CANN NAIL-EX 180MM/RT-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14487476
• MDR Text Key: 292490188
• Report Number: 2939274-2022-01882
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087232
• UDI-Public: (01)10886982087232
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.008.216S
• Device Catalogue Number: 04.008.216S
• Device Lot Number: H490998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: 4.5 MM CANNULATED.; UNK - SCREWS: 4.5 MM CANNULATED.; UNK - SCREWS: FOOT - 5.0MM.; UNK - SCREWS: FOOT - 5.0MM.; UNK - SCREWS: FOOT - 6.0MM.; UNK - SCREWS: FOOT - 6.0MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female