MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MINI LENGTHENING APPARATUS 110MM; MANDIBLE DISTRACTION DEVICES

Model Number	394.071
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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.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.A device history record review has been requested.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 after a metatarsal osteotomy procedure on (b)(6) 2018, the turning wheel and screw for the mini lengthening apparatus fell off while the patient was at home with the device.Another wheel and screw were provided and placed on the existing device.Patient status is unknown.This report is for a mini lengthening apparatus 110mm.This is report 1 of 1 for (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.H3, h4, h6: device history part: 394.071, lot: 1l03301, manufacturing site: bettlach, release to warehouse date: 04.Sep.2018.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Device history batch null, device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, which would contribute to this complaint condition.H3, h6: investigation summary product was not returned.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.

• Brand Name: MINI LENGTHENING APPARATUS 110MM
• 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: 8254301
• Report Number: 2939274-2019-55896
• Device Sequence Number: 13991937
• Product Code: MQN
• UDI-Device Identifier: 10886982199539
• UDI-Public: (01)10886982199539
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K973018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2018

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: 394.071
• Device Catalogue Number: 394.071
• Device Lot Number: 03301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1