MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8MM CANNULATED CURVED AWL; MISC ORTHO SURGICAL INSTR

Model Number	03.037.008
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
Occupation: reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported on an unknown date while putting the sets back together after going through the decontamination process, the monobloc flexible reamer and medullary reamer head have appeared to be dull during an inspection.An awl was also noticed to have an issue where the rubber on the handle of the awl was damaged and coming off.All the reported devices were no longer usable.There were no patient and surgical involvement.This report is for one (1) 8mm cannulated curved awl.This is report 2 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.Flow: damage.Visual inspection: upon visual inspection of the instrument it can be seen that a bottom portion of the blue silicone rubber of the handle has ripped apart/missing from the instrument and was not returned.No additional damage was noted.A device failure was identified.Dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage.Document specification based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation conclusion: the exact cause of the complaint condition cannot be determined as the handling and use of the device are unknown.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part number: 03.037.008.Lot number: t121164.Manufacturing site: (b)(4).Release to warehouse date: nov 26, 2015.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: 8MM CANNULATED CURVED AWL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9178947
• Report Number: 2939274-2019-61348
• Device Sequence Number: 11436192
• Product Code: LXH
• UDI-Device Identifier: 10886982070258
• UDI-Public: (01)10886982070258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2019

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: 03.037.008
• Device Catalogue Number: 03.037.008
• Device Lot Number: T121164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/22/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1