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

Catalog Number 352.040

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

It was reported than on (b)(6) 2018, a flexible shaft is no longer holding reamer heads well.It was unknown if there was any surgical delay.There was no patient consequence reported.Concomitant devices reported: unknown reamer heads (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves (1) device.This report is 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device history records review was completed for part: 352.040, lot: 2030734.Manufacturing location: bettlach, release to warehouse date: sep 03, 2002.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Visual inspection observed no issues on the instrument.The device is in fair condition with minimal signs of wear and tear.A functional test could not be performed as the reamer head that resulting the discovery of the complaint issue was not returned.The received condition does agree with the complaint description and could not be replicated.Dimensional inspection as per the drawing: outer ø of distal tip: 5.8 +0/-0.1 mm, inner ø of distal tip: 2.9 +/- 0.1 mm.Measured dimensions: outer ø: 4.71 mm; nonconforming.Inner ø: largest gauge pin fit 2.50 mm; nonconforming.Device used: calipers ca592 and gauge pin gp29.A review of the current design drawing and the drawing revision at the time of manufacture was performed and no issues were identified.The complaint condition was confirmed.A definitive root cause for the given complaint condition could not be determined from the provided information.However, the device is reusable device that hasb been in the field for 16+ years and constant use has led to the dimensions no longer being in specification and resulting in not functioning as intended.During the investigation, no product design or manufacturing issues 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.

• 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
• MDR Report Key: 7932430
• MDR Text Key: 122632722
• Report Number: 2939274-2018-54148
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 2030734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Date Manufacturer Received: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1