MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5MM HEX FLEXIBLE SCREWDRIVER; MISC ORTHO SURGICAL INSTR

Catalog Number 03.037.028

Device Problems Bent (1059); Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.Device is an instrument and is not implanted/explanted.Patient code is used to capture the no patient involvement.A device history record (dhr) review was performed for part no.: 03.037.028, lot no.: 9345768: manufacturing location: (b)(4), release to warehouse date: 11.May.2015: no non-conformance reports (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 cannulated flexible shaft broke at the transition between the most proximal flexible link and the proximal shaft.The complaint is confirmed.The shaft of the screwdriver is also bent.Replication of the complaint condition is not possible as the device is already broken.The device shows minor surface wear which does not impact functionality.The outer diameter of the shaft closest to the break was measured and is within specifications based on relevant drawing.Relevant drawings were reviewed during investigation.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, including material, that would contribute to this complaint condition.No definitive root cause could be determined however, it is likely that the device experienced excessive off axis force.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.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 the cannulated handle is broken on a 5mm hex flexible screwdriver.It was found broken in sterile processing.No procedure involvement.During manufacturer¿s investigation it was identified that the returned cannulated flexible shaft broke at the transition between the most proximal flexible link and the proximal shaft.The shaft of the screwdriver is also bent.This condition was re-evaluated and determined to be reportable on (b)(6) 2018.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 5MM HEX FLEXIBLE SCREWDRIVER
• 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 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7399002
• MDR Text Key: 104735136
• Report Number: 2939274-2018-51468
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982070449
• UDI-Public: (01)10886982070449(10)9345768
• 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: Other
• Type of Report: Initial
• Report Date: 02/06/2018

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: 03.037.028
• Device Lot Number: 9345768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1