MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER; SCREW,FIXATION,BONE

Model Number	04.005.528S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of postoperative nonunion development is unknown.Original implant date is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.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 that a patient was implanted with a synthes 11 mm titanium (ti) cannulated tibial nail to treat an unknown tibia fracture on an unknown date.Postoperatively, on an unknown date, it was identified that there was a non-union of the fracture and on (b)(6) 2017, the patient was returned to the operating room where the nail was removed and the patient was revised using an unknown tibial nail.The procedure was completed successfully.This report is for one (1) 5.0 mm ti locking screw w/t25 stardrive 38 mm f/im nail-sterile.This is report 5 of 6 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record review was performed for the subject device manufacturing location: monument.Manufacturing date: 18-nov-2015, expiration date: 31-oct-2024.Part #: 04.005.528s, lot#: 9928308 (sterile) - 5.0mm ti locking screw w/t25 stardrive 38mm f/im nail - sterile.Quantity 140.Inspection sheet for whirl, threads, vibe, flute final inspection meet specification.Component parts reviewed: part: 04.005.528.999, 5.0mm ti screw blank 38mm lot: 9813996.Lot was release to bp55 on 08-jun-2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.¿sterility documentation was reviewed and determined to be conforming.¿ no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7164119
• Report Number: 2939274-2018-50069
• Device Sequence Number: 13947863
• Product Code: HWC
• UDI-Device Identifier: 10886982085979
• UDI-Public: (01)10886982085979(17)EXPIRATIONDATEUNKNOWN(10)9928308
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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 Expiration Date: 10/31/2024
• Device Model Number: 04.005.528S
• Device Catalogue Number: 04.005.528S
• Device Lot Number: 9928308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention