MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS

Model Number	309.035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, during a hardware removal of an unknown proximal femur plating construct, a couple of unknown screw removal extractors were broken and damaged.All broken pieces were successfully removed.There was unknown surgical delay.The procedure successfully completed.Patient outcome is unknown.This complaint involves seven (7) devices.This report is for (1) hollow reamer complete for 3.5mm & 4.0mm screws.This report is 1 of 1 (b)(4).
Event or Problem Description
This is report 1 of 6 for (b)(4).

• Brand Name: HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11867294
• Report Number: 2939274-2021-02513
• Device Sequence Number: 19107397
• Product Code: HTO
• UDI-Device Identifier: 10886982185549
• UDI-Public: 10886982185549
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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 Model Number: 309.035
• Device Catalogue Number: 309.035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONICAL XTRCTION SCR 1.5&2.0 CORTEX SCRS; EXTRACTION BOLT FOR 2.0MM SCREWS; EXTRACTSCR F/SCR Ø3.5; HOLLOW REAMER COM FOR 3.5 & 4.0 SCRS; HOLLOW REAMER-COMPLETE FOR 2.0MM SCREWS; SPARE REAM TUBE HOLLOW REAM (309.035)