MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RIA DRIVESHAFT L360; REAMER

Catalog Number	314.742
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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, reports an event in (b)(6) as follows: it was reported that, on an unknown date, during an in-house inspection, the shaft in front on an ria driveshaft l360, is found to be broken.No patient involvement.This complaint involves one (1) device.This report is for one (1) ria driveshaft l360.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.Investigation site: cq zuchwil.Selected flow: damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: the hexagon piece at the forefront of the received ria drive shaft is broken off at the crossover from the hexagon to the shaft.The fragment was not returned for evaluation.In general is the device is a very used condition, there are strong stress marks at the shaft and the coupling piece has clearly visible wear marks at the surfaces.Dimensional inspection: checked dimensions.The reamer / irrigator / aspirator (ria) surgical technique (036.000.553 dsem/trm/0615/0404(1) 09/15) 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.Investigation conclusion: the complaint is confirmed as the hexagon at the forefront of the ria drive shaft is broken off as complained.The age, the used condition and the performed evaluation let us exclude a manufacturing related issue.There was no information provided when or how the device broke, therefore no definite root cause can be defined.It can only be assumed that incorrect assembling or too much applied torque did lead to a mechanical overload and finally 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 lot : part number: 314.742, synthes lot number: 6073843, supplier lot number: 16076-01, release to warehouse date: jan 26, 2009, expiration date: n/a, supplier: criterion tool & die, inc.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: RIA DRIVESHAFT L360
• Common Device Name: REAMER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9270772
• Report Number: 8030965-2019-69942
• Device Sequence Number: 13492889
• Product Code: HTO
• UDI-Device Identifier: 07611819739192
• UDI-Public: (01)07611819739192
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 16076-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1