MAUDE Adverse Event Report: SYNTHES GMBH POSTERIOR FOOT-MEDIUM 12MM OFFSET F/MAXILLARY DSTR; BONE PLATE

Catalog Number 288.056

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) posterior foot-medium 12mm offset f/maxillary dstr.This is report 3 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 number: 288.056.Lot number: 12l7093.Date of manufacture: 10/21/2019.Place of manufacture: brandywine.Part expiration date: n/a (non sterile).List of non conformances: none.Device history review.Description of dhr review: no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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.11.Corrected data.

• Brand Name: POSTERIOR FOOT-MEDIUM 12MM OFFSET F/MAXILLARY DSTR
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11244355
• MDR Text Key: 229326968
• Report Number: 8030965-2021-00697
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819743632
• UDI-Public: (01)07611819743632
• 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: 288.056
• Device Lot Number: 12L7093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Patient Sequence Number: 1
• Treatment: ANT-FOOT-PL LEFT 10 F/MAXILL-DISTR MONOA; MAXILL-DISTRACTOR MAIN BODY MONOAX DISTR
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR