MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Catalog Number 314.742

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is synthes sales representative.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an incoming inspection the drive shaft was discovered as broken off at the tip.No patient involvement reported.This report is for one (1) drive shaft-minimum 360mm 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.Visual inspection: the ria drive shaft was received at cq with the distal hexagonal tip broken; fragments were not returned for investigation.Besides, the instrument presents normal signs of use.Dimensional inspection: inner shaft diameter specification 3.76mm +/-0.05 / measured: 3.75mm = pass.Outer shaft diameter specification 5.18mm +/-0.025 / measured: 5.17mm = pass diameter hexagon across flat specifications: 4.4mm +0/-0.05mm / measured: not possible due to the damage document/specification review: no issues.The reamer / irrigator / aspirator (ria) surgical technique was reviewed during this evaluation, following relevant sections were identified: precaution: improper assembly can result in product breakage, which may lead to surgical delay, bone damage, and/or adverse tissue damage.Note: do not use a reduction drive.Drills with a torque greater than 6 nm must not be used.Power equipment designed for reaming must not be used material /hardness review: the material and material properties of the returned part were determined to be conforming at the time of manufacture based on review of the dhr.Summary: the complaint condition is confirmed as the ria drive shaft (part # 314.742) was received with the distal hexagonal tip broken.This production lot (7929050) was manufactured in september 2015 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.Based on the provided information ¿ damage noted during loan kit inspection - we are not able to determine the exact cause of this occurrence.However, the damage is most likely that incorrect assembling or too much applied torque did lead to a mechanical overload and finally caused the breakage of the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history part #: 314.742, synthes lot #: 7929050, supplier lot #: 7929050, release to warehouse date: 23-sep-2015, supplier: (b)(4).The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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 360MM LENGTH-FOR USE WITH RIA
• Type of Device: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10314065
• MDR Text Key: 200066146
• Report Number: 8030965-2020-05197
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819739192
• UDI-Public: (01)07611819739192
• 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: 07/03/2020

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: 314.742
• Device Lot Number: 7929050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/23/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1