MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM FLEXIBLE SHAFT; REAMER

Model Number 352.040

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales consultant.A product investigation was conducted.Visual inspection: the 5.0mm flexible shaft (p/n: 352.04, lot number: 9083275) was received at us cq sealed in packaging.Sealed packaging was opened during investigation.Upon visual inspection, it was observed that one (1) of the tip prongs was bent outward.Additionally, scratches were observed on the shaft of the complaint device, which were consistent with normal wear.Faded etching was observed on the proximal end of the device.No other issues were identified.Dimensional inspection: following dimensions measured as per relevant drawings.Specified dimensions: tip id = measured dimensions, conforming, shaft od = measured dimensions, conforming.Document/specification review: the relevant drawing(s) were reviewed: no design issues or discrepancies were identified.Investigation conclusion: this complaint was confirmed since one (1) of the tip prongs was bent outward.Additionally, scratches and fading of etch were observed.While no definitive root cause could be determined, it is possible the device encountered unintended forces.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.A device history record (dhr) review was conducted: part: 352.040, lot: 9083275.Manufacturing site: bettlach.Release to warehouse date: 04.August 2014 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 on an unknown date, the 5.0mm flexible shaft was noticed damaged and needs to be replaced.It is unknown how the issue was discovered.There were no patient and surgical involvement reported.During manufacturer's investigation of the returned device it was observed that one (1) of the tip prongs was bent outward.Additionally, scratches were observed on the shaft of the complaint device, which were consistent with normal wear.Faded etching was observed on the proximal end of the device.This product condition was re-evaluated and determined to be reportable on september 14, 2020.This report is for one (1) 5.0mm flexible shaft.This is report 1 of 1 for (b)(4).

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10550739
• MDR Text Key: 207578029
• Report Number: 2939274-2020-04190
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352.040
• Device Catalogue Number: 352.04
• Device Lot Number: 9083275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2014
• 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