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

Catalog Number	314.742
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hrx.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 or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, during an unknown procedure, the reamer/ irrigator/ aspirator (ria) drive shaft of the ria system broke while reaming.It was noted no fragments were generated when the device broke.It was a standard situation upon reaming the ria system forward and backward.The surgeon used another ria drive shaft as well as the assembly to successfully complete the procedure.There was a surgical delay of five (5) minutes with no patient consequence reported.Concomitant device reported: ria tube (part/lot unknown, quantity 1); ria medullary reamer heads (part/lot unknown, quantity 1).This report is for an ria drive shaft.This is report 1 of 1 for (b)(4).
Additional 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.H10 additional narrative: h3, h4, h6: the drive shaft-minimum 360 mm length for use with ria (part # 314.742) was received with the distal tip broken.This is consistent with the reported complaint condition, thus confirming the complaint.Unknown reamer head and unknown ria assembly was received as concomitant device without any alleged allegations.Upon visual inspection, there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.Dimensional inspection: internal diameter of shaft was measured 3.75 mm using gauge pins which is within specification during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Dhr review: the returned device was manufactured in january 12, 2016 at criterion site.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.The material was reviewed, and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.Conclusion: the complaint condition is confirmed as the ria drive shaft (part # 314.742) was received with the distal tip of the device broken.There is no indication that a design or manufacturing issue contributed to the complaint.No definitive root cause was able to be determined with the provided information.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number: 314.742.Synthes lot number: 9943612.Supplier lot number: n/a.Release to warehouse date: 12/12/2016.Expiration date: n/a.Supplier: (b)(4), inc.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 360MM LENGTH-FOR USE WITH RIA
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8441208
• Report Number: 8030965-2019-62145
• Device Sequence Number: 16434861
• Product Code: HTO
• UDI-Device Identifier: 07611819739192
• UDI-Public: (01)07611819739192
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K042899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 314.742
• Device Lot Number: 9943612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1