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

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 (b)(6) 2021, the patient underwent revision surgery due to a broken hip.The patient experienced serious pain in the hip.The x-ray revealed the nail was broken.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.This report is for one (1) unk - nails: femoral.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images attached in the notes & attachments section of pc titled "(b)(4): xray image 1" and "(b)(4): xray image 2." the images were reviewed and the complaint condition is confirmed.The femoral nail appears to be broken at the interface with the lag screw in the images provided.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was found in the photos or provided, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical part is received.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.During the investigation, no product design issues or discrepancies were observed (based on the image) 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 history lot - no valid lot number was found in the photos or provided, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical part is received.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: FEMORAL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12892930
• MDR Text Key: 281406180
• Report Number: 2939274-2021-06855
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/30/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/01/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female