MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM; REAMER

Model Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is company representative investigation summary visual inspection: the device was received and inspected.It was noticed that the device's distal tip was broken off.The complaint is confirmed.The broken piece was not returned.Dimension inspection: it was not performed due to post manufacturing damage and broken piece was not returned.Conclusion: the complaint is confirmed.It is possible that the device encountered unintended forces (during usage or handling at the time of surgery).During the investigation no unidentified product design/manufacturing 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history part # 357.403, synthes lot # u333012, supplier lot # u333012, release to warehouse date: 15 nov 2019, supplier: orchid unique, no ncr's were generated during production.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 february 27, 2020, the patient underwent an unknown procedure.During reaming at the right femur to collect bone graft, the reamer head broke.The reamer head was removed with a guide wire but there were some fragments retained in the femur.There was an attempt to suction out the fragments but that failed.The guide wire was bent in an extreme curve to preferentially ream and collect ria graft from distal femur.The surgeon forced the ria reamer down over the bend of the wire and broke the reamer head.Fragments of the reamer head were left in the femur.The reamer head was removed via the ball tip guide wire.During opening the entry hole, the tip of a stepped cannulated drill bit broke.It is unknown if there was a surgical delay.The procedure was successfully completed.The patient's status is unknown.Concomitant device reported: guide wire (part# 351.706s, lot# unknown, quantity# 1).This is report 1 of 2 for (b)(4).

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9882426
• Report Number: 2939274-2020-01532
• Device Sequence Number: 2857377
• Product Code: HTO
• UDI-Device Identifier: 10886982196262
• UDI-Public: (01)10886982196262
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: 357.403
• Device Catalogue Number: 357.403
• Device Lot Number: U333012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1
• Patient Age: 43 YR