MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CURVILINEAR DISTRACTOR STRAIGHT; MANDIBLE DISTRACTION DEVICES

Model Number	04.500.218
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Relevant actions have been taken to address the issue.Device was used for treatment, not diagnosis.Patient information not available for reporting.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the surgeon was preparing the straight 1.3mm curvilinear distractors for implantation and the distraction knob broke off on two (2) different implants during a procedure on (b)(6) 2018.The fragments were easily removed with no additional intervention.The surgery was successfully completed with no delay and with no effect on patient outcome.This complaint involves two (2) devices.This report is 1 of 2 for (b)(6).
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.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.

• Brand Name: 1.3MM CURVILINEAR DISTRACTOR STRAIGHT
• Common Device Name: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7329540
• Report Number: 2939274-2018-50990
• Device Sequence Number: 19201668
• Product Code: MQN
• UDI-Device Identifier: 10887587016832
• UDI-Public: (01)10887587016832(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K121502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 04.500.218
• Device Catalogue Number: 04.500.218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR