MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T25 STRDRV 10MM EXT HUMERAL NAIL-EX SPIRAL BLADE; NAIL,FIXATION,BONE

Model Number	04.001.002
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.(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 (b)(6) 2019, the patient underwent a hardware removal as planned.Initially, the patient had an implantation using an expert humeral nailing system in (b)(6) 2018.An end cap was successfully explanted from the patient and was sent to pathology for examination.There was unknown time of surgical delay.The patient was in good health.Concomitant device reported: unk - nails: expert humeral (part# unknown, lot# unknown, quantity 1), unknown locking screw (part# unknown, lot# unknown, quantity unknown), unknown spiral blade (part# unknown, lot# unknown, quantity 1).This is report 1 of 1 for (b)(4).Related product complaint: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3,h6: investigation summary 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.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation due to the item was released to the patient.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: TI END CAP T25 STRDRV 10MM EXT HUMERAL NAIL-EX SPIRAL BLADE
• 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: 9592184
• Report Number: 2939274-2020-00203
• Device Sequence Number: 16310390
• Product Code: JDS
• UDI-Device Identifier: 10886982080769
• UDI-Public: (01)10886982080769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.001.002
• Device Catalogue Number: 04.001.002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - NAILS: EXPERT HUMERAL; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention