MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.160S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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 that on an unknown date, the tfna nail was broken.It is unknown if there was a surgical delay.Procedure outcome and patient status are unknown.Concomitant device reported: unk- helical blade (part # unknown; lot # unknown; quantity: unknown), unk - screws: locking (part # unknown; lot # unknown; quantity: unknown).This report is for one (1) 11mm/130 deg ti cann tfna 400mm/right - sterile.This is report 1 of 1 for (b)(4).
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.Visual inspection: the 11mm/130 deg ti cann tfna 400mm/right - sterile (p/n: 04.037.160, lot number: h693627) was received at us customer quality (cq).Visual inspection of the complaint device showed the device was broken at the proximal slot.Drill marks were observed within the slot.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: head od = 15.66 +/- 0.1mm measured dimensions: head od distal to break = 15.63mm, conforming head od proximal to break = 15.63mm, conforming device used - caliper ca818.Document/specification review: current and manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device has broken at the proximal slot and shows drill marks.Pie and pia has been launched to address the identified issue.The need for further corrective/preventive action will be assessed within the pie.Further investigation will not be conducted in this complaint as it will be addressed within pie.No definitive root cause could be determined based on the provided information.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: 11MM/130 DEG TI CANN TFNA 400MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10404200
• Report Number: 2939274-2020-03526
• Device Sequence Number: 2991080
• Product Code: HSB
• UDI-Device Identifier: 10886982096685
• UDI-Public: (01)10886982096685
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 04.037.160S
• Device Catalogue Number: 04.037.160S
• Device Lot Number: H693627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM TI LCK SCRW W/T25 STARDRV 54MM F IM NAIL; 5.0MM TI LOCK SCRW W/T25 STARDR 60MM F IM NAIL; TFNA HELICAL BLADE 100MM STERILE; UNK - END CAPS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 86