MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM; NAIL,FIXATION,BONE

Model Number	212.119
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).Additional product code: ktt.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 a cancer patient had a section of the tibia with tumor removed.A fresh frozen allograft was implanted along with a 3.5mm locking compression plate (lcp) medial proximal tibia plate ten (10) screws on (b)(6) 2018.On unknown date it was determined patient developed a non-union due to the breakage of five (5) of the screws.Patient was returned to surgery on (b)(6) 2018.All screws were fully removed.Patient was revised to a large fragment 12-hole plate and eight (8) screws.Surgery was completed successfully with no delay.Concomitant devices: 3.5mm lcp medial proximal tibia plate (part 239.965, lot 5383454, quantity 1).3.5mm locking screw 18mm (part 212.105, lot unknown, quantity 1).3.5mm locking screw 20mm (part 212.106, lot unknown, quantity 1).3.5mm cortex screw 22mm (part 204.822, lot unknown, quantity 1).3.5mm cortex screw 24mm (part 204.824, lot unknown, quantity 1).3.5mm cortex screw 26mm (part 204.826, lot unknown, quantity 1).This report is for one (1) 3.5mm locking screw 45mm.This is report 5 of 5 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.Date of event : exact date of event is unknown; event reportedly occurred in 2018.A product investigation was completed: the 3.5 mm locking screw self tapping with stardrive (tm) recess 45 mm (part number 212.119, lot number unknown) was not returned for physical evaluation.The following investigation is based on review of the provided medical images.Upon review of the images provided, the complaint condition of broken (2+ pieces) postoperatively could be confirmed for three (3) screws only.As the implant was not returned an as received, dimensional, material or drawing reviews are not applicable.A dhr review for the manufacturing records and the material records could not be performed as the lot number is unknown.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM
• 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: 8155347
• Report Number: 2939274-2018-55361
• Device Sequence Number: 244045
• Product Code: JDS
• UDI-Device Identifier: 10886982151933
• UDI-Public: (01)10886982151933
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 212.119
• Device Catalogue Number: 212.119
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR