MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.034.658S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 6¿10¿ date of event: date patient pain began is not known.Date of implant reported as 5 to 6 years prior to explant.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was 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.
Event or Problem Description
It was reported patient was implanted with a tibial nail approximately 5 to 6 years prior to removal.On unknown date, patient reported pain.It was determined the nail was rubbing against the patella.Patient was returned to surgery on (b)(6) 2018 where the nail and screws were removed fully intact.Surgery was completed successfully with no delay.Patient was not revised to additional hardware and is reported as stable.Concomitant devices reported: locking screw (part number unknown, lot number unknown, quantity unknown).This report is for one (1) 12mm cannulated tibial nail-ex.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device: manufacturing location: (b)(4).Manufacturing date: 04-jun-2009.Expiration date: 30-apr-2018.Part #: 04.034.658s, lot#: 6150903 (sterile) - 12mm ti cann tibial nail - ex w/prox bend 390mm - sterile.Quantity 6.Component parts reviewed: part 21012, lot 5846782 reviewed.Raw material was received from supplier (b)(4), certificate of test for titanium ingot received from (b)(4) meet specification.Inspection certificate received from (b)(4) meet specification.Raw material receiving/put away checklist meets specification.Inspection sheet for in-process acceptance (b)(4) met inspection acceptance criteria.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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: 12MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-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: 7394321
• Report Number: 2939274-2018-51426
• Device Sequence Number: 16191932
• Product Code: JDS
• UDI-Device Identifier: 10886982095534
• UDI-Public: (01)10886982095534(17)180430(10)6150903
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 04.034.658S
• Device Catalogue Number: 04.034.658S
• Device Lot Number: 6150903
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/03/2018
• Supplement Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 143