MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RIA TUBE ASSEMBLY MIN 520 LNTH-S 314.743; REAMER

Model Number	314.746S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hrx.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: manufacturing location: (b)(4), inspected, packaged and released by: (b)(4), release to warehouse date: 29-jun-2020, expiration date: 31-may-2022, part number: 314.746s, ria tube assembly min 520mm length-sterile for 314.743, lot number: 42p3104 (sterile), lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Certificate of analysis supplied by (b)(4) dated 04-jun-2020 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection, (b)(4) rev e met all inspection acceptance criteria.Packaging label log (pll) lppf rev g, lmd rev a was reviewed and determined to be conforming.(b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history review: oct 27, 2021.(b)(6).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 on (b)(6) 2021, the patient underwent for a surgery.During the surgery, while performing the ria portion, the tube assembly became clogged and would not allow the flow of the bone graft.While attempted to disassemble the driveshaft from the tube assembly, and it was lodged inside of the tube assembly.The driveshaft was somewhat damaged while trying to remove it from the tube assembly.The ria tube assembly was clogged, and the drive shaft became lodged inside of the assembly tube.The procedure was completed successfully with a surgical delay of 10 minutes.There was no patient consequence reported.Concomitant device reported: unk - screws: 2.4mm cortex (part # unknown; lot # unknown; quantity: 1).This complaint involves three (3) devices.This report is for one (1) unk - screws: locking.This is report 1 of 1 for (b)(4).

• Brand Name: RIA TUBE ASSEMBLY MIN 520 LNTH-S 314.743
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12787767
• Report Number: 2939274-2021-06592
• Device Sequence Number: 3840343
• Product Code: HTO
• UDI-Device Identifier: 10886982189080
• UDI-Public: (01)10886982189080
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/15/2021

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: 05/31/2022
• Device Model Number: 314.746S
• Device Catalogue Number: 314.746S
• Device Lot Number: 42P3104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SFT-MINIMUM 520 LNTH-FOR USE RIA; UNK - SCREWS: CORTEX
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 104 KG