MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11/130 DEG TI CANN TFNA 235/RIGHT - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.144S

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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, the surgeon implanted a 130-degree tfna nail with a lag screw.Post-operative measurements were taken, and he measured the angle between the nail and the lag screw to be 123.9 degrees.No revision surgery or hardware removal is required.This report is for (1) 11/130 deg ti cann tfna 235/right - sile.This is report 1 of 2 for complaint (b)(4).

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: 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.

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: h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the photo.Visual analysis of the image showed it is not possible to determine if there is a product defect.The measured angle from the film would indicate that it is a 125 degree nail.It is possible that a 125 degree nail was selected by mistake, or potentially mislabeled either on the nail itself or on the exterior package label.Note; if the aiming arm assembly was set up for a 130 degree nail and used to target a 125 degree nail the drill bit would have struck and damaged the nail, insertion of the lag screw would be difficult if not impossible.There is no sign of nail damage visible on the film; metal chips, burrs or gouges on the nail.The lag screw is coaxial and well centered in the locking hole which is further evidence that the trajectory of the lag screw was guided by an aiming arm matching the angle of the locking hole in the nail.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 the 11/130 deg ti cann tfna 235/right - sile.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.H6: a device history record (dhr) review was conducted: manufacturing location: monument.Manufacturing date: 09-oct-2021.Expiration date: 31-aug-2031.Part number: 04.037.144s, 11mm/130 deg ti cann tfna 235mm/right-sterile.Lot number: 430p504 (sterile).Lot quantity:(b)(4).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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿angle between nail and lag screw measured at 123.9 degrees¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported 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: 11/130 DEG TI CANN TFNA 235/RIGHT - SILE
• 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: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13525152
• MDR Text Key: 285612097
• Report Number: 2939274-2022-00481
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096562
• UDI-Public: (01)10886982096562
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.144S
• Device Catalogue Number: 04.037.144S
• Device Lot Number: 430P504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEM: TFNA LAG SCREW
• Patient Outcome(s): Required Intervention