MAUDE Adverse Event Report: SYNTHES GMBH ANTERIOR FOOT F/MAXILLARY DSTR MAXILLA LEFT/SPLINT RIGHT/10MM; BONE PLATE

Catalog Number 288.043

Device Problem Mechanical Jam (2983)

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

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.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

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the maxillary distractor had done for the patient for right and left sides.But two weeks later it was realized that the left side of patient¿s teeth distractor had gone back to 3mm instead of 11mm.It was unknown if any removal or revision surgery scheduled.The patient consequences were reported.This complaint involves three (3) devices.This report involves one (1) anterior foot f/maxillary dstr maxilla left/splint right/10mm.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Product complaint #(b)(4).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.H10 additional narrative: h3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.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 # 288.043.Synthes lot # 14l1251.Supplier lot # 14l1251.Supplier batch # h488618.Release to warehouse date: jan 15, 2020.Supplier: jabil-monument.(b)(4) was generated during production for discoloration.Part was returned to vendor.This non-conformance is not relevant to the complaint condition since it is not related to distraction for the left side of the maxillary distractor had distracted to 11mm.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: ANTERIOR FOOT F/MAXILLARY DSTR MAXILLA LEFT/SPLINT RIGHT/10MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11244360
• MDR Text Key: 229326803
• Report Number: 8030965-2021-00696
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819743588
• UDI-Public: (01)07611819743588
• Combination Product (y/n): N
• PMA/PMN Number: K020505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 288.043
• Device Lot Number: 14L1251
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2021
• Patient Sequence Number: 1
• Treatment: MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR; POST-FOOT-PL 20*12 F/MAXILL-DISTR MONOAX
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR