MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.449S
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product was not returned.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 or Problem Description
It was reported on (b)(6) 2019, the patient underwent hardware removal of a titanium cannulated tibial nail due to hardware breakage.The surgery was delayed approximately two hours due to the difficulty of hardware removal.The extraction bolt was threaded into the proximal portion of the nail for removal and an additional surgical incision/tunnel was made through the heel to mallet out the distal segment of the nail.There was no alleged deficiency with any instrumentation or any implant leading to the difficult removal other than the nail/screw breakage.Procedure outcome and patient status are unknown.This is report 1 of 1 for (b)(4).(b)(4) captures the postoperative event of hardware breakage while (b)(4) captures the intraoperative event of the actual revision surgery.
Event or Problem Description
The extraction bolt was threaded into the proximal portion of the nail for removal and an incision/tunnel was made through the heel to mallet out the distal segment of the nail.
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.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.
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.H6: code 3191 used to capture medical device removal.H11 corrected information: h6 device code.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: 10MM TI CANNULATED TIBIAL NAIL-EX/345MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8757604
• Report Number: 2939274-2019-59000
• Device Sequence Number: 2296295
• Product Code: JDS
• UDI-Device Identifier: 10886982084217
• UDI-Public: (01)10886982084217
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/04/2019

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: 04.004.449S
• Device Catalogue Number: 04.004.449S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/01/2019; 01/29/2020
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/29/2019; 01/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention