MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.743

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported on an unknown date that the end of the drive shaft has snapped off.This case was reported by the loan kit technician during loan kit inspection.This report is for one (1) drive shaft-minimum 520mm length-for use with ria.This is report 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.Investigation flow: damage.Visual inspection: the ria drive shaft l520 (p/n: 314.743, lot #: 7312608) was returned and received at us cq.Upon visual inspection the physical product and reviewing attached pictures in the "victoria.Msg" attachment, the complaint description can be confirmed that the connection tip of ria driveshaft is completely broken off.The broken fragment was not returned.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the device received condition.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the ria drive shaft l520 (p/n: 314.743, lot #: 7312608).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 # 314.743, synthes lot # 7312608, supplier lot # 7312608, release to warehouse date: aug 19, 2013; jan 30, 2014, supplier: (b)(4).No ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, 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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10795151
• MDR Text Key: 215131129
• Report Number: 8030965-2020-08677
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739208
• UDI-Public: 07611819739208
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2020

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: 314.743
• Device Lot Number: 7312608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/08/2020
• Patient Sequence Number: 1