MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING PERSUADER HANDLE; MISC. ORTHO, SURGICAL INSTRUMENT

Catalog Number	03.615.042
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2018, a persuader came apart from the handle during a posterior spinal fusion, persuader mouth plunged into incision site.It was unknown if there was any surgical delay.Surgery and patient outcome are unknown.This report is for (1) locking persuader handle.This complaint involves two (2) device.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.A review of the device history records has been requested.The device has been 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.
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.
Event or Problem Description
It was reported that the patient had no movement in the right leg.
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 history lot.Part number: 03.615.042.Synthes lot number: t116638.Release to warehouse date: 07-mar-2016.Manufacture site: (b)(4).Part expiration date: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used raw material was according to the specification of the device.No ncrs were generated during the production of this device.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.Investigation summary.Visual inspection: there were no visual defects that were observed.The connection between the persuader and the persuader handle appears to be loose.Functional test: holding the instrument at an angle when the persuader and the persuader handle are attached properly and then squeezing the handle, does not cause the persuader to fall off from the handle.If the instrument is handled roughly while the handle is in the closed position, then the persuader can separate from the handle and fall off.Under normal conditions the persuader and the persuader handle connection are loose, but the persuader does not just fall apart.Therefore, the complaint is unconfirmed for falling apart but is confirmed for the connection being loose.Dimensional inspection: dimensional analysis was completed, the inner diameter of the large tip, measured 10.84 mm which is within specification of 10.8 mm to 10.9 mm.Conclusion: the complaint condition is confirmed as the device (part # 03.615.042, lot # t116638) was received with the persuader handle and the persuader intact but loose.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: LOCKING PERSUADER HANDLE
• Common Device Name: MISC. ORTHO, SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8010202
• Report Number: 2939274-2018-54638
• Device Sequence Number: 18869133
• Product Code: LXH
• UDI-Device Identifier: 10705034715353
• UDI-Public: (01)10705034715353
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.615.042
• Device Lot Number: T116638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 11/13/2018; 12/05/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/12/2018; 11/30/2018; 12/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention