MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLLOW REAMER-COMPLETE FOR 4.5MM SCREWS

Model Number	309.450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 conclusion could be drawn.Based on the information available, it has been determined that no corrective and/or 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 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 an unknown date, during hip revision surgery, the spare reamer tube for hollow reamer was broken.The user put the spare reamer tube on power and circled around the screw while at full speed, resulting in a break at the sharp end of the trephine.The broken piece was retrieved and removed easily from the body.A new instrument was opened.The hollow reamer was used with spare reamer tube on a power drill.One of the teeth on the hollow reamer broke off during the bone clearing process.There was a surgical delay of three (3) minutes.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity # unknown), unknown drill (part # unknown, lot # unknown, quantity # unknown).This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).
Event or Problem Description
Update: it was reported that on an unknown date, the patient underwent a hip revision surgery to remove the implants due to nonunion.There was a surgical delay of three (3) minutes.Procedure was successfully completed.Patient outcome is unknown.  this (b)(4) captures intra-operative event, while (b)(4) was created to capture post-operative event.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional information provided for reporting.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: HOLLOW REAMER-COMPLETE FOR 4.5MM 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: 8698029
• Report Number: 2939274-2019-58649
• Device Sequence Number: 14022094
• Product Code: HTO
• UDI-Device Identifier: 10886982185730
• UDI-Public: (01)10886982185730
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 309.450
• Device Catalogue Number: 309.450
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/08/2019
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 59