MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL GUIDE

Model Number	312.155
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.Reporter is synthes employee.A device history record (dhr) review was conducted for part # 312.155, synthes lot # 6005159, supplier lot # na: release to warehouse date: 31dec2008, manufactured by synthes (b)(4): no non-conformance reports (ncr¿s) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was conducted.The instrument was received with the reported condition of ¿visual deformed/bent: nrm & broken (2+ pieces) pre or post operatively/step unknown: nrm¿.The following investigation flow were performed: damage: visual (appearance not as expected).It was visually observed that the drill guide is not broken instead the drill guide portion of the instrument is bent inward at the juncture between the guide and handle.The balance of the device is in fair condition.The received condition does agree with the complaint description for bent, however not for broken.The complaint is confirmed.Dimensional inspection: drill guide length and shaft diameter were measured and found to be conforming per relevant drawing.A review of the current design drawing and the drawing revision at the time of manufacture was performed and no issues were identified.Based on the available information it is not possible to determine a definitive root cause for the complaint condition a possible cause could be rough handling during the device¿s 7+ year lifespan has resulted in the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 that during an inspection of sets, the loaners department found that the one (1) drill guide and two (2) matrixmidface drill bits were broken, bent and non-repairable.There was no patient involvement.This is report 3 of 3 for complaint (b)(4).

• Brand Name: 1.5MM DRILL GUIDE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7813355
• Report Number: 2939274-2018-53455
• Device Sequence Number: 19340254
• Product Code: FZX
• UDI-Device Identifier: 10887587036489
• UDI-Public: (01)10887587036489
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial
• Report Date (Section B): 06/28/2018

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: 312.155
• Device Catalogue Number: 312.155
• Device Lot Number: 6005159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1