MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL; REAMER

Model Number	351.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device returned.Reporter is a synthes rep.Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, 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 an unknown date, during sterile processing department (spd), two (2) flexible shaft connector for use with hand drill was found broken.There was no patient involvement.This complaint involves two (2) devices.This report is for one (1) flexible shaft connector for use with hand drill.This report is 1 of 2 for (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the customer reported the device was broken.The repair technician reported the device missing parts.Missing parts is the reason for repair.The cause of the issue is missing parts.The following parts were replaced: chuck pin.The item was repaired per the inspection sheet, passed synthes final inspection on 27-jan-2020 and will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history: lot: part: 351.16j; lot: 2713297; manufacturing site: (b)(4); release to warehouse date: 17.Mar.2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: FLEXIBLE SHAFT CONNECTOR FOR USE WITH HAND DRILL
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9633316
• Report Number: 2939274-2020-00430
• Device Sequence Number: 11616678
• Product Code: HTO
• UDI-Device Identifier: 10886982193735
• UDI-Public: (01)10886982193735
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 351.16
• Device Catalogue Number: 351.16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1