MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.037.025

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 on (b)(6) 2018, a patient underwent a trochanteric fixation nail advanced (tfna) procedure.During the surgery, the surgeon tried to take off the percutaneous radiolucent insertion handle after having placed and locked down the tfna femoral nail, titanium alloy and lag screw.However, the connecting screw for insertion handle would not release from the nail.The patient¿s leg was abducted and the connecting screw could not be removed.The surgeon then removed the instrumentation and implants.A new second nail of the same part and different sized lag screw were inserted, and another new second connecting screw and insertion handle were used.The same issue occurred.The connecting screw became stuck to the nail while taking off the second insertion handle.The surgeon was able to disengage the connecting screw from the nail.The second nail and lag screw remained implanted in the patient.It was noted that the nail was not fitting on properly, and that the tips of both insertion handles had become bent or torqued.It was also noted that the screw inserter bent at the handle and the helical blade/screw coupling screw bent at the tip of the threads.There was an unknown surgical delay reported.Additional medical intervention was required.The patient outcome was also unknown.The procedure was successfully completed.Concomitant device reported: trochanteric fixation nail advanced (tfna) screw 100mm - sterile (part 04.038.100s, lot h406590, quantity 1); trochanteric fixation nail advanced (tfna) screw 110mm - sterile (part 04.038.110s, lot 7859799, quantity 1).This is report 6 of 8 for (b)(4).

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.Device history record (dhr) review: part: 03.037.025; lot: 9604297; manufacturing site: bettlach; release to warehouse date: september 23, 2015; the device history record shows this lot of 48 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacturing process.The manufacturing documents were reviewed and no complaint related issues were found.Investigation summary: flow: device interaction/functional visual inspection- the screw inserter (part 03.037.025, lot 9604297, mfg 23.Sep.2015) was received at us customer quality (cq) with signs of use but no other visual deformations.Threads of the device were inspected under magnification and no defect were noted.Functional test- a functional test was completed, the returned connecting screws,the returned screw inserter fully threaded with the helical blade/screw coupling screw (part 03.037.026, lot 9768853) and fit flush with the concomitant trochanteric fixation nail advanced (tfna) screw (04.038.100s, lot h406590).The construct disassembled as intended, however, operational conditions could not be re-created.This is not consistent with the reported complaint condition, the complaint was not able to be replicated, therefor the complaint is unconfirmed.Conclusion- the complaint condition is unconfirmed as the screw inserter (part 03.037.025, lot 9604297) was received with no visual defects and performed functionally as intended.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the operational context and patient specific anatomy played a role in the issues noted by the surgeon.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: SCREW INSERTER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7561438
• MDR Text Key: 109839943
• Report Number: 2939274-2018-52383
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070418
• UDI-Public: (01)10886982070418
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.025
• Device Catalogue Number: 03.037.025
• Device Lot Number: 9604297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1