MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTER FOR TI ELASTIC NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number 359.219

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2018

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part no.: 359.219, lot no.: 9564239: manufacturing location: (b)(4), release to warehouse date: 09.Nov.2015: 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.A product investigation was performed.The inserter for titanium elastic nails (359.219) is used with a hammer guide and locking slide hammer for insertion of titanium elastic nails (ten) and stainless steel elastic nails (sten).The inserter is also used in end cap insertion and removal.This information is provided per the elastic nail system technique guide.The returned inserter was examined upon receipt and the complaint condition was able to be confirmed as the blue handle was found to be broken near the proximal end; witness marks consistent with impaction were noted on the handle.No definitive root cause was able to be determined however, based on the witness marks; it is likely that the complaint condition is a result of errant hammer blows.Additionally it was noted that the chuck teeth were missing and not returned which would inhibit the device from being able to grasp the elastic nail.This failure is likely the result of instrument disassembly for sterile processing resulting in lost subcomponents.The complaint condition was able to be replicated as the chuck will not open or close without teeth.A review of the current design drawing and the drawing revision at the time of manufacture (11/2015) was performed.The handle design was modified to improve impact resistance to hammer strikes and material was changed from ppsu blue-301 to pom-c blue-502 ((b)(4) ¿ 07/09/2016).This device was manufactured to revision a prior to the design/material changes.No dimensional analysis is applicable due to post-manufacturing damage.During the investigation no discrepancies were observed that may have contributed to the complaint condition.Review of the device history records, including material and hardness reviews, showed that there were no mrrs, ncrs or issues identified during the manufacture of the products that would contribute to this complaint condition.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.

Event Description

It was reported that during a bilateral femoral elastic nail insertion on (b)(6) 2018 the chuck handle inserters would not tighten down on the elastic nails.One of the handles was discovered to have a crack in the plastic handle.There was a reported 10-minute delay in surgery as the surgeon attempted to get the inserters to work.The surgery was successfully completed using a t-handle chucks from another set.During the manufacture¿s investigation of the returned device, it was identified that the blue handle of the inserter for ti elastic nails was found to be broken near the proximal end.This condition was re-evaluated and determined to be reportable on (b)(6) 2018.Concomitant device reported: unknown elastic nails (part number unknown, lot number unknown, quantity unknown).This is report 1 of 1 for complaint (b)(4).

• Brand Name: INSERTER FOR TI ELASTIC NAILS
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7495258
• MDR Text Key: 108166765
• Report Number: 2939274-2018-52081
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982197214
• UDI-Public: (01)10886982197214
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 359.219
• Device Lot Number: 9564239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR