MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM; PLATE, BONE

Catalog Number 04.503.405.01S

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter is a synthes sales representative 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 Description

Device report from synthes (b)(6) reports an event as follows: on (b)(6) 2020, a removal procedure was performed to remove the screws.During the screw removal, a thin string-like silver foreign object was found.They tried to figure out where the foreign object came from but were not able to identify it.The original procedure occurred on (b)(6) 2016.This report is for a matrix mandible screw.This is report 5 of 10 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: this mre review is for sterilization procedure only.Part: 04.503.405.01s.Lot: 9837603.Manufacturing site: bettlach.Supplier: (b)(4).Release to warehouse date: 23.February 2016.Expiry date: 01.February 2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in monument.Part: 04.503.405.20.Lot: 9901940.Manufacturing location: monument.Manufacturing date: 14-sep-2015.Part number: 04.503.405.20, 2.0mm ti matrixmandible screw self-tapping 5mm.Lot number: 9901940 (non-sterile).Lot quantity: 120.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.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.Component part(s) reviewed: part number: 21015, tialnbri4.00.Lot number: 9839306.Lot quantity: 1,284 lbs.Certified test report dated 05-jun-2015 was reviewed and determined to be conforming.Lot summary report dated 17-jun-2015 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.Product was not returned and therefore, no further investigation is possible.This complaint will be rated as confirmed as the investigation has shown that the observed damage is consistent with the reported complaint condition.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.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: 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10950091
• MDR Text Key: 243567572
• Report Number: 8030965-2020-09405
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819939318
• UDI-Public: (01)07611819939318
• Combination Product (y/n): N
• PMA/PMN Number: K063790
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.405.01S
• Device Lot Number: 9837603
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 12/09/2020
• Patient Sequence Number: 1
• Treatment: LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L12 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L14 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L16 TAN 1U I/CLIP; LOCK SCR Ø2 SELF-TAP L6 TAN 1U I/CLIP; MATMAND PL STRAIG 6HO T1.5 TI; MATMAND SCR Ø2.4 SELF-TAP L6 TAN 1U I/CL; MATRIXMAND MINI-TENSIONPL NARROW CENTRE