MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC RIA TUBEASSEMBLY MIN-L 520 F/314.743; REAMER

Model Number	314.746S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device is an instrument and is not implanted/explanted.Dhr review was completed.Part # 314.746s.Synthes lot # h381679.Supplier lot # h381679.Expiration date: 31 aug 2019.Release to warehouse date: 28 sep 2017.Manufactured by synthes (b)(4).No ncr¿s were generated during production.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.Customer quality conducted an investigation of the returned device.The returned instrument (part 314.746s, lot h381679, mfg 28 sep 2017) was inspected at customer quality and the complaint was confirmed.Whether this complaint could be replicated is not applicable because the device was returned damaged.Upon visual inspection, it was noted that the ria tube assembly had a puncture just proximal of the reamer head attachment; consistent with the complaint condition.Dimensional analysis could not be performed as relevant features are significantly deformed or not returned.Drawing (current and mfg) were reviewed and no design issues were identified.Dhr review showed no ncr¿s were generated during production.Material and relevant testing occurred at the time of manufacture and confirmed to have no issues through the dhr review.Based on the complaint condition, it is probable that the drive shaft punctured a hole in the tubing.During the investigation, no 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.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 while using the reamer irrigator aspirator (ria), the reamer drive shaft disengaged from the ria tube assembly, the ria clip fell off of the assembly, the tip of the ria drive shaft snapped off, and perforated a small hole in the end of the ria tube assembly.Surgery was delayed approximately 2 minutes while a second ria was opened and assembled.No patient consequence was reported.Investigation of the returned ria tube assembly showed the device to be broken.This report is for one (1) ria tube assembly.(b)(4).

• Brand Name: RIA TUBEASSEMBLY MIN-L 520 F/314.743
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7259871
• Report Number: 2939274-2018-50573
• Device Sequence Number: 19023521
• Product Code: HTO
• UDI-Device Identifier: 10886982189080
• UDI-Public: (01)10886982189080(17)190831(10)H381679
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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 Expiration Date: 08/31/2019
• Device Model Number: 314.746S
• Device Catalogue Number: 314.746S
• Device Lot Number: H381679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 68