MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE; SCREWDRIVERS

Model Number	313.97
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Occupation: initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A review of the device history records has been requested.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 (b)(6) as follows: it was reported that on an unknown date, the shaft of an unknown screwdriver would not introduce into the holding sleeve during an orthognathic surgery bimaxillary.It is unknown if there was surgical delay.Procedure outcome is unknown.There was no patient consequence.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) holding sleeve.This is report 1 of 1 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.Service & repair evaluation: the customer reported the device was unable to assemble with its mating device.The repair technician reported that the customer had an incorrect spring with the device.Missing parts is the reason for repair.The cause of the issue is unknown.The following parts were replaced: spring.The item was repaired per the inspection sheet, passed synthes final inspection, and will be returned to the customer upon completion of the service and repair process.Service record router completed through operation 30.Finalized service record will be archived.The evaluation was confirmed.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.H3, h4, h6: a device history record (dhr) review was conducted: part number: 313.97, synthes lot number: 7687290, supplier lot number: n/a, release to warehouse date: 27-may-2014, expiration date: n/a, manufactured by synthes jennersville.No non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: HOLDING SLEEVE
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8196355
• Report Number: 2939274-2018-55570
• Device Sequence Number: 1653083
• Product Code: HXX
• UDI-Device Identifier: 10887587037196
• UDI-Public: (01)10887587037196
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2018

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: 313.97
• Device Catalogue Number: 313.97
• Device Lot Number: 7687290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/23/2019; 03/01/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/12/2019; 03/01/2019
• Patient Sequence Number: 1