MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 16MM; MANDIBLE DISTRACTION DEVICES

Model Number 488.076

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 Description

It was reported that during a maxilla distraction on (b)(6) 2020, the alveolar distractor broke during the case.Upon opening the distractor/osteotomy, the distractor gear broke, thus rendering it unusable.The surgeon has to force the removal of the broken distractor and reimplant a 12mm distractor.It was also mentioned that due to the reported issue, two (2) emergency screws had to be used because the previous screw holes became stripped out when trying to place the screws back in.The procedure was successfully completed.There was a 15 minutes or less surgical delay reported.Patient status was good.Concomitant device reported: 2.0 mm titanium emergency screws (part # 400.276e, lot # unknown, quantity 2).This complaint involves one (1) device.This report involves one (1) ti alveolar distractor with straight plate 16mm.This report is 1 of 1 for (b)(4).

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- product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot = part/lot combination are unknown at synthes gmbh, no dhr review possible.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: TI ALVEOLAR DISTRACTOR WITH STRAIGHT PLATE 16MM
• Type of Device: MANDIBLE DISTRACTION DEVICES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11194913
• MDR Text Key: 227576282
• Report Number: 2939274-2021-00363
• Device Sequence Number: 1
• Product Code: MQN
• UDI-Device Identifier: 10887587056128
• UDI-Public: (01)10887587056128
• Combination Product (y/n): N
• PMA/PMN Number: K043555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 488.076
• Device Catalogue Number: 488.076
• Device Lot Number: 205200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Patient Sequence Number: 1
• Treatment: 2.0MM TI ER SCW W/ PLSDR(TM) RECS 6MM; 2.0MM TI ER SCW W/ PLSDR(TM) RECS 6MM; 2.0MM TI ER SCW W/ PLSDR(TM) RECS 6MM; 2.0MM TI ER SCW W/ PLSDR(TM) RECS 6MM