MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: RFNA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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

Patient Problem Loss of Range of Motion (2032)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - nails: rfna/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 Description

It was reported that on unknown date, patient underwent a procedure.The surgeon reported that a flexion deformity occurred on x-ray following implantation of a retrograde intramedullary nail through the femoral component of a knee prosthesis.It was noted that after full insertion of the nail, a minor flexion deformity was noted on x-ray.It is unknown if there was a surgical delay noted.The procedure was successfully completed.There were no fragments generated noted.There were no patient consequences.Concomitant devices reported: unk - screws: locking(part# unknown, lot# unknown, qty unknown).Unk - end caps: rafn(part# unknown, lot# unknown, qty unknown).Unk - nail head elements: rafn spiral blade(part# unknown, lot# unknown, qty unknown).This complaint involves one(1) device.This report is for (1) unk - nails: rfna.This report is 1 of 1 for (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.H10 additional narrative: h3, h6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images.The images were reviewed, and the complaint condition could not be confirmed.The photos show the leg not fully straight which could be indicative of a flexion deformity but as a static image, it cannot be definitively concluded that this represents the extent of the range of motion.The possible flexion deformity cannot definitively be linked to the implant.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: UNK - NAILS: RFNA
• 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 Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12497839
• MDR Text Key: 272225839
• Report Number: 2939274-2021-05590
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/23/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: RAFN; UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - SCREWS: LOCKING; UNK - END CAPS: RAFN; UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention