MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC; SCREWDRIVERS

Model Number	313.932
Medical Device Problem Code	Material Twisted/Bent (2981)
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.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.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 an unknown date, two (2) low profile neuro cruciform screwdriver blades were damaged.It is unknown if there were a procedure and patient involvement.This complaint involves two (2) devices.This is 2 of 2 for report (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 device history record (dhr) review: a dhr file could not be reviewed as it has not yet been scanned into tungsten as of (b)(6) 2019 , but jde confirmed that the lot was released for sale (b)(6) 2019.If a dhr file becomes available in the future, the review (of the dhr) will be revisited.A search in mdd non-conformance module confirmed that no non-conformances occurred during manufacture.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: LOW PROFILE NEURO SCRWDRVR BLD SLF-RETAIN/CRUCIFORM/MED/HXC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9342409
• Report Number: 2939274-2019-62280
• Device Sequence Number: 2145374
• Product Code: HXX
• UDI-Device Identifier: 10887587037059
• UDI-Public: (01)10887587037059
• Combination Product (Y/N): N
• 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): 11/04/2019

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: 313.932
• Device Catalogue Number: 313.932
• Device Lot Number: U340908
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 12/24/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1