MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Model Number 314.743

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional product code hrx.The device was received, the investigation is in progress, 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 (b)(6) 2020, during an unknown procedure there are two products that involved these are the reamer head-sterile for reamer/irrigator/aspirator and drive shaft-minimum 520mm length for use with ria.Both the ria drive shaft and ria head broke where they attach to each other.There was a surgical delay only a couple of minutes.Procedure was successfully complete the other ria drive shaft and new head was used successfully.Patient was involved but there is no adverse events.Patient status was good after surgery.This complaint involves 2 devices.This report is for (1) drive shaft-minimum 520mm length-for use with ria.This report is 2 of 2 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.Visual inspection: the drive shaft-minimum 520mm length-for use with ria (part #: 314.743, lot #: h299358) was returned and received at us cq.Upon visual inspection, it was observed that the reamer head component was broken off the drive shaft.No other issues were identified with the returned device.Device failure/defect was identified.Dimensional inspection: dimensional inspection of the received device was performed at cq.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint was confirmed.Investigation conclusion: the complaint condition was confirmed for the drive shaft-minimum 520mm length-for use with ria (part #: 314.743, lot #: h299358).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.Device history lot part number:314.743, synthes lot number: h299358, supplier lot number: n/a, release to warehouse date: oct 11, 2017, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Device history review review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11013111
• MDR Text Key: 222311362
• Report Number: 2939274-2020-05598
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982189042
• UDI-Public: (01)10886982189042
• Combination Product (y/n): N
• PMA/PMN Number: K042899
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.743
• Device Catalogue Number: 314.743
• Device Lot Number: H299358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/30/2020
• Patient Sequence Number: 1
• Treatment: 14.0MM REMR HEAD-STRL FR REMR/IRGTR/ASPRTR
• Patient Age: 67 YR