MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING; SCREWDRIVERS

Model Number	313.939
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on october 31, 2018, during inspection in the sterile processing department, it was found out that the screwdriver blade shaft keeps sticking inside the holding sleeve and it did not happened during a case.There was no patient involvement.This report is for one (1) 2.4/3.0mm cruciform scrwdrvr blade with hex coupling.This is report 1 of 2 for complaint (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.Device history lot part # 313.939.Synthes lot # 7790911.Supplier lot # na.Release to warehouse date: 04 mar 2015.Manufactured by synthes (b)(4) the lot was reinspected to the correct sampling size with no product nonconformity identified.This non-conformance is not relevant to the complaint condition since as the issue is unrelated to the fit with the holding sleeve and the sampling size was corrected.Review of the device history record(s) showed that there were no issues during the manufacture of the product that 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: 2.4/3.0MM CRUCIFORM SCRWDRVR BLADE WITH HEX COUPLING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8075147
• Report Number: 2939274-2018-55001
• Device Sequence Number: 1721679
• Product Code: HXX
• UDI-Device Identifier: 10887587037127
• UDI-Public: (01)10887587037127
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Report Date (Section B): 12/18/2018

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: 313.939
• Device Catalogue Number: 313.939
• Device Lot Number: 7790911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1