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

Model Number 352.040

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).Device received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 on october 14, 2019, the reamer heads were slipping off the flexible shaft, the attachment would not fully engage.There was no surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: 5.0mm flexible shaft (part#: 352.040, lot# unknown, quantity# 1).This complaint involves one (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.H10 additional narrative: h3, h6: investigation summary.Flow: device interaction/functional.Visual inspection: upon visual inspection, it was noticed that the device was received intact.The distal tabs were found intact.The device had severe scratches.The part number/ lot number were hard to read.There is no other damages or any breakages were noticed on the returned device.Functional test: functional test could not performed as no mating device was returned for investigation.Dimension inspection: a dimensional inspection was not performed as no breakage or damage was observed on returned device during the visual inspection.Also dimensional inspection is not relevant to the condition of scratches and illegible etches.Complaint confirmed: no.Conclusion: based on visual inspection, the complaint cannot be confirmed as well as reported condition cannot be replicated as no mating device was received.The exact cause of the reported condition is unknown.For scratches and illegible etch condition, it is likely that the device was used heavily worn during the 8+ year life of the device.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part 352.040 lot 2665765; manufacturing location: bettlach; manufacturing date: nov 30, 2010; no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history review: no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.

Event Description

It was reported that on (b)(6) 2019, the reamer heads were slipping off the flexible shaft, the attachment would not fully engage.The reamer shaft would not hold the reamer heads and this will be returned.The reamer shaft is the reason for the device failure, not the reamer heads.There was no surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown reamers: reamer head (part# unknown, lot# unknown, quantity# 1).

• 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: 9258581
• MDR Text Key: 190375149
• Report Number: 2939274-2019-61848
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 352.040
• Device Lot Number: 2665765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 11/21/2019
• Patient Sequence Number: 1
• Treatment: UNK - REAMERS: REAMER HEAD.; UNK - REAMERS: REAMER HEAD.