MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT

Catalog Number	03.111.600
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record review was requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that during an orthopedic procedure on (b)(6) 2017, a set screw stripped and broke when the surgeon was removing the guide block just before finishing the surgery.No fragments were generated.The surgery was successfully completed with no surgical delay and the patient was stable after the surgery.There is no additional information.(b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 03.111.600, lot no.: 14-3995, manufacturing location: (b)(4), supplier: (b)(4), release to warehouse date: 09.Apr.2014: no non-conformance reports (ncrs) were generated during production.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.Corrected data: device manufacture date.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
Complainant device is not expected to be returned for manufacturer review/investigation.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: GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7117874
• Report Number: 8030965-2017-50683
• Device Sequence Number: 11179879
• Product Code: FZX
• UDI-Device Identifier: 10886982072528
• UDI-Public: (01)10886982072528(10)14-3995
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2017

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 Catalogue Number: 03.111.600
• Device Lot Number: 14-3995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 01/15/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/12/2018; 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1