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

Model Number	351.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in usa as follows: it was reported that during intramedullary reaming of the left femur for an insertion of a trochanteric fixation nail advanced (tfna) nail on (b)(6) 2019, the flexible shaft connector broke apart into its individual components when the user was removing the flexible reamer from the patient under normal use.It was mentioned that the devices connected to shaft connector were not damaged.The procedure was successfully completed without a surgical delay.Patient status was unknown.Concomitant device reported: unknown chuck (part # unknown, lot # unknown, quantity unknown), unknown drill (part # unknown, lot # unknown, quantity unknown), unknown flexible reamer shaft (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is for one (1) flexible shaft connector for use with hand drill.This is report 1 of 1 for (b)(4).
Event or Problem Description
This report is for a flexible shaft connector for use with jacobs chuck.
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.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.
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 investigation summary.Service & repair evaluation: the customer reported that during intramedullary reaming of the left femur for insertion of a trochanteric fixation nail advanced (tfna) nail on (b)(6) 2019, the flexible shaft connector broke apart into its individual components when the user was removing the flexible reamer from the patient under normal use.The repair technician reported the device is missing the check sleeve part.Missing part is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Visual inspection: the flexible shaft connects for use with jacobs chuck (p/n: 351.16j, lot #: 2627642) was returned and received at us cq.Upon visual inspection, it was observed that the device was missing a check sleeve and screw.No other issues were identified with the returned components of the device.Device failure/defect identified? yes dimensional inspection: no dimensional inspection can be performed due to missing components.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed: connector assembly flexible shaft handle complaint confirmed? yes, the device received is missing components.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the flexible shaft connect for use with jacobs chuck (p/n: 351.16j, lot #: 2627642).There is no indication that a design or manufacturing issue has caused it and hence the root cause cannot be determined.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 number: 351.16j synthes lot number: 2627642 manufacturing site: bettlach release to warehouse date: 23.July 2010.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 JACOBS CHUCK
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9439973
• Report Number: 2939274-2019-62551
• Device Sequence Number: 2387582
• Product Code: HTO
• UDI-Device Identifier: 10886982193735
• UDI-Public: (01)10886982193735
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2019

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: 351.16
• Device Catalogue Number: 351.16J
• Device Lot Number: 2627642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 11/24/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 01/21/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/08/2020; 01/23/2020
• 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: UNK - CHUCK; UNK - DRILL; UNK - FLEXIBLE REAMER SHAFT
• Patient Age: 82 YR