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

Catalog Number	314.743
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement.It is unknown when the event occurred.Additional procodes: hrx.Device is an instrument and is not implanted/explanted.Complainant part has been received, however, product investigation is not yet completed; no conclusion could be drawn.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
It was reported that during a internal inspection activity by the depuy synthes service and repair department, two (2) drive shafts for use the (ria) reamer irrigator aspirator instrument were found with tips broken on each instrument.No patient involvement.This complaint involves two (2) device.This report is for one (1) drive shaft.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part number: 314.743, synthes lot number: 7432391, supplier lot number: n/a: release to warehouse date: 12-feb-2014, expiration date: n/a, supplier: (b)(4).No non-conformance reports (ncrs) were generated during production.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.A product investigation was performed.The returned ria drive shaft (314.743, 7432391) is included in the reamer/irrigator/aspirator (ria) system used for intramedullary reaming and bone harvesting.The returned shaft was found to have its distal tip broken off, which confirmed its complaint condition and made its replication inapplicable.The returned ria drive shaft (314.743, 7432391) was manufactured on 12-feb-2014 and relevant drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s), which would contribute to the complaint condition.The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/ available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Due to post-market damage of the distal tip of the shaft, no relevant features could be effectively measured.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.Considering the potentially challenging circumstances experienced during reaming/ aspiration/ irrigation it is possible that the cumulative effect of exposure to extreme conditions during its lifespan caused the tip of the drive shaft to become vulnerable to breakage.Also, if reaming was performed on unusually dense/ hard bone the cumulative effect of the subsequent forces experienced by the tip of the drive shaft could have contributed to the complaint condition.It was reported that the shaft was found to be broken after sterilization, but not during or after the procedure it was last used in.Based on the available info it is possible that the shaft either not being stored properly during sterilization, or being handled in a rough manner during processing, contributed to the breakage of its distal tip.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
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7249308
• Report Number: 2939274-2018-50542
• Device Sequence Number: 997610
• Product Code: HTO
• UDI-Device Identifier: 10705034801049
• UDI-Public: (01)10705034801049(10)7432391
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 314.743
• Device Lot Number: 7432391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1