MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 40MM; APPLIANCE,FIXATION,NAIL

Model Number 412.214

Device Problem Break (1069)

Patient Problems Bone Fracture(s) (1870); Discomfort (2330); Not Applicable (3189)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 Description

It was reported that initially on (b)(6) 2018 a patient underwent, the open reduction internal fixation (orif) of the left femur, wherein the surgeon implanted a titanium broad locking compression plate without any reported issues.On an unknown postoperative date, the patient complained of a twinge feeling in his leg.Radiology images were taken and revealed a broken plate at the previous fracture site.Patient underwent the revision surgery with orif to treat the femoral shaft peri prosthetic fracture and take down malunion on (b)(6) 2018.During revision surgery the surgeon explanted the broken titanium broad locking compression plate and replaced it with a new plate, screws, cable and bone graft.All fragments were removed without complications.There were no issues during the revision surgery.The surgery was completed successfully.Patient was stable after surgery.Preliminary investigation of the returned devices revealed one of the 5.0mm locking screws is broken.It is not known if the device was broken prior to or during the removal procedure.The 4.5mm titanium threaded cerclage positioning pin (498.803, lot h476436, quantity 4), 5.0mm titanium locking screw 40mm (412.214, lot 9197607, quantity 1), 5.0mm titanium locking screw 40mm (412.214, lot 8539201, quantity 1), 5.0mm titanium locking screw 14mm (412.201, lot 8569203, quantity 1), 5.0mm titanium locking screw 26mm (412.207, lot l592115, quantity 1), 5.0mm titanium locking screw 38mm (412.213, lot l011791, quantity 1), 4.5mm titanium cortex screw 40mm (414.840, lot unknown, quantity 2).This report is for one (1) 5.0mm locking screw.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Dhr review was completed.Part: 412.214.Lot: 9747695.Manufacturing site: (b)(4).Release to warehouse date: 30.Nov.2015.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specification for implants for surgery review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Us cq investigation workflow: broken.Visual inspection performed at cq observed that screw was broken at the head.The head was returned, the shaft was not.Based on visual inspection, the received condition agreed with the complaint condition from the ir activity - the complaint condition was confirmed.Dimensional inspection of the broken screw could not be conducted due to post-manufacturing damage.Device history record(s) showed that there were no issues during the manufacture of this product including the materials and its properties, which would contribute to this complaint condition.The relevant drawing for the returned device was reviewed during the investigation: this revision was current at the time of the device¿s manufacture and was current at the time of this investigation.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Risk assessment review: the design and clinical risk management (dcrm) document was reviewed.The complaint is adequately addressed by the risk assessment.Conclusion: the complaint condition of a broken screw was confirmed.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.The complaint condition is adequately addressed by the risk assessment.While no definitive root cause could be determined, it is possible that the screw experienced abnormal forces while implanted.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.

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.Patient identifier also reported as gmh.Date of event is an unknown date in 2018.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 Description

It was reported that patient underwent open reduction internal fixation (orif) on (b)(6) 2018 due to comminuted, segmental, periprosthetic, left femoral shaft fracture.Patient was implanted with titanium periprosthetic plates and screw, synthes cable system, left femur (liss plate placement).Fracture was reduced with multiple bone clamps.A crutch was directed at the fracture apex to aid in the reduction process.Two (2) cables were placed at either end of the butterfly fragment to maintain a reduction.On an unknown postoperative date, the patient complained of a twinge feeling in his leg.Radiology images were taken and revealed a broken plate at the previous fracture site.On (b)(6) 2018, patient underwent revision and hardware removal surgery due to mal-union and breakage of the periprosthetic plate.During the procedure, the implants were removed and replaced with a new peri-prosthetic plate, multiple 4.5mm cortical and locking cortical screws, 3 large stainless steel synthes cables, 2 cortical struts, multiple cables, mixed 40cc of cancellous bone chips with 15cc of demineralized bone matrix (dbx) bone putty.All fragments were removed without complications.The surgery was completed successfully.Patient was stable after surgery.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 40MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7934163
• MDR Text Key: 122665417
• Report Number: 2939274-2018-54156
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982210982
• UDI-Public: (01)10886982210982
• Combination Product (y/n): N
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 412.214
• Device Catalogue Number: 412.214
• Device Lot Number: 9747695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR