MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS RADIOLUCENT INSERTION HANDLE; ROD, FIXATION, INTRAMEDULLARY

Model Number	03.037.112
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id/initials, age/date of birth and weight are unknown device is an instrument and is not implanted/explanted.(b)(4).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 or Problem 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 4 of 8 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.Device history record (dhr) review: part number: 03.037.112; lot number: 9760926; manufacturing location: haegendorf; release to warehouse date: january 05, 2016; no nonconformance records (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.No ncrs were generated during production.Investigation summary: flow: device interaction/functional.Visual inspection: the insertion handle (part 03.037.112, lot 9760926, mfg 05.Jan.2016) was received at us customer quality (cq) with extreme torqueing deformation to the tab intended to interface with the trochanteric fixation nail advanced (tfna) nail.The damage is consistent with the reported condition.Functional test: a complete functional test could not be completed as operational conditions could not be re-created.However, the returned insertion handle could not be engaged with the returned tfna nail as the tab was deformed.Since the handle could not be assembled with the nail replication of the complaint condition, unable to disassemble, was not possible.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed by post manufacturing damage.Document/specification review: the device drawings from the time of manufacturing and current drawings were reviewed.Dhr review showed no ncr¿s were generated during production.Conclusion: the complaint condition is confirmed as the insertion handle (part 03.037.112, lot 9760926) was received with post manufacturing damage.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 device encountered unintended forces during disassembly of the instruments causing the damage.No new malfunctions were observed during the course of this investigation.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: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• 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: 7561349
• Report Number: 2939274-2018-52381
• Device Sequence Number: 19147870
• Product Code: HSB
• UDI-Device Identifier: 10886982070562
• UDI-Public: (01)10886982070562
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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: 03.037.112
• Device Catalogue Number: 03.037.112
• Device Lot Number: 9760926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 07/09/2018
• 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