MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 14MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.462S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Date of Event	01/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part has not been returned for manufacturer review/investigation.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 the patient underwent a revision for a non-union of a right femur subtrochanteric fracture on (b)(6) 2017 due to a broken tfn-advanced proximal femoral nailing system (tfna) nail.The patient was implanted with a nail, helical blade and distal locking screw in early (b)(6) 2017.On an unknown date, the patient felt a snap in his thigh and was referred to a different surgeon.It was noted that the nail had broken at the top portion where the helical blade passes through.All hardware was removed.Due to damaged instruments, there was a 10-15 minute surgical delay.The fracture was reduced and the patient was revised to a shorter tfna nail.The procedure was completed successfully.Patient outcome is stable.Concomitant devices reported: helical blade (part # unknown, lot # unknown, quantity # 1), distal locking screw (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).This report is for a nail.
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Correction: device is an implant with a implant and explant date.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
For concomitant part # unknown helical blade, part number was identified as # 04.038.285s and lot number was identified as # h394815.
Additional Manufacturer Narrative
Therapy date: (b)(6) 2017; exact date is unknown.Patient code (b)(4) is used in initial mw to capture additional medical/surgical intervention required.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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
This complaint is linked with (b)(4) for the intra-operative event (damaged instruments).
Additional Manufacturer Narrative
Date of postoperative nail breakage is unknown.Date of event is reported inadvertently on initial medwatch.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.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A device history record review was performed for the subject device; part #: 04.037.462s, lot#: h369888 (sterile) - 14mm/130 deg ti cann tfna 420mm/right- sterile.Quantity 5.Manufacturing location: (b)(4).Manufacturing date: 23-may-2017 expiration date: 30-apr-2027 component parts reviewed: 04.037.942.2 - lock prong 130 degree, tfna bp-55 lot - l376224; 04.037.912.4 - wave spring, shim ended bp-55 lot - h249499; 04.037.912.3 - tfna lock drive bp-58 lot - h357422.21127 - raw material lot bp-80 lot - h126763.Raw material was received from supplier (b)(4).Certificate of test received for (b)(4) ingot from howmet castings meet specification.Raw material receiving/putaway checklist meets specification.Inspection sheet for in-process/inspect dimensional/final and inspection sheet - tfna assembly inspection 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 the product that would contribute to this complaint condition.Scn no: (b)(4) (ethicon, (b)(4)), ¿sterility documentation was reviewed and determined to be conforming.¿ a manufacturing investigation was performed for the subject device.The returned nail was confirmed to be broken at the hole for the head element.The complaint was confirmed.Replication of the complaint condition is not applicable as the device is already broken.The remainder of the nail was intact with minor wear related to implant and explant.Drawings were reviewed during investigation.No product design issues or discrepancies were observed.The outer diameter of the nail proximal to the breakage measured 15.67mm which is within the specification of 15.66mm +/- 0.1.Review of the device history record showed that there were no issues during the manufacture of this product, including material and material properties, which would contribute to this complaint condition.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 14MM/130 DEG TI CANN TFNA 420MM/RIGHT-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7213876
• Report Number: 2939274-2018-50381
• Device Sequence Number: 997864
• Product Code: HSB
• UDI-Device Identifier: 10886982097668
• UDI-Public: (01)10886982097668(17)EXPIRATIONDATEUNKNOWN(10)836988
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/03/2018

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: 04.037.462S
• Device Catalogue Number: 04.037.462S
• Device Lot Number: H369888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/23/2018; 01/29/2018; 03/02/2018; 03/02/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 01/26/2018; 01/30/2018; 03/02/2018; 03/02/2018
• 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