MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR; MANDIBLE DISTRACTION DEVICES

Model Number	04.315.132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 on (b)(6) 2019 during a mandible distraction for a corrective jaw surgery the removable extension arm-flex for a curvilinear distractor was broke while trying to engage the distraction arm with the distractor.The surgery was delayed sixty (6) minutes.Patient status and surgical outcome were unknown.Concomitant devices: unk - distractor (part unknown, lot unknown, quantity unknown).This report is for one (1) removable extension arm-flex 60mm for cmf distractor.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h4.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
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, h6: part: 04.315.132, lot: h796490, part manufacture date: november 13, 2019, manufacturing location: brandywine, part expiration date: n/a, nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of removable extension arm-flex 60mm for cmf distractor product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the removable extension, flexible craniofacial distractor was returned and received at us customer quality (cq).Upon visual inspection, no issues were identified with the returned components of the device.Investigation conclusion the complaint condition is un-confirmed for the removable extension, flexible craniofacial distractor as no issues were identified during visual inspection.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: REMOVABLE EXTENSION ARM-FLEX 60MM FOR CMF DISTRACTOR
• 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: 9438863
• Report Number: 2939274-2019-62580
• Device Sequence Number: 3603824
• Product Code: MQN
• UDI-Device Identifier: 10887587015682
• UDI-Public: (01)10887587015682
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.315.132
• Device Catalogue Number: 04.315.132
• Device Lot Number: H796490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 12/09/2019; 01/13/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/06/2020; 01/15/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DISTRACTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR