MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM; PLATE, BONE

Catalog Number 04.503.616.01S

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 matrixmandible plate.This is report 10 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.H3, h6: this mre review is for sterilization procedure only: part: 04.503.616.01s, lot: 9885792, manufacturing site: bettlach, supplier: früh verpackungstechnik ag, release to warehouse date: 29.March 2016, expiry date: 01.March 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: 04.503.616.20, lot: 9937958.Manufacturing location: monument, manufacturing date: 18-dec-2015.Part number: 04.503.616.20, 2.0mm ti matrixmandible locking screw slf-tpng 16mm, lot number: 9937958 (non-sterile), lot quantity: 60.Work order traveler met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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: 04.503m616, 2.0mm ti matrixmandible locking screw slf-tpng 16mm, lot number: 9937958, lot quantity: 60.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Packaging label log lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Part number: 21015, tialnbri4.00, lot number: 9878452, lot quantity: 2,269 lbs.Certified test report dated 13-jul-2015 was reviewed and determined to be conforming.Lot summary report dated 12-aug-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.Visual inspection: a unknown part such as a burr (fine wire) was received at customer quality zuchwil for investigation.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Dimensional inspection: a dimensional test is not appropriate, as the reported complaint condition is about a foreign substance and not due to dimensional issues.Conclusion: our investigation has shown that the complaint condition is confirmed as a foreign substance, most likely a burr (fine wire) from a screw, was sent back for investigation.Because the involved screw were not sent back for investigation, the foreign substance cannot be addressed to the corresponding screw.A device history record review was performed for all the reported article/lot combination as part of this investigation.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the burr is a result of friction between the involved devices during removal procedure for the implants which were in situ for approx four (4) years.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 LOCKING SCREW SLF-TPNG 16MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10950392
• MDR Text Key: 219880405
• Report Number: 8030965-2020-09414
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819939813
• UDI-Public: (01)07611819939813
• 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: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.616.01S
• Device Lot Number: 9885792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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 L6 TAN 1U I/CLIP; MATMAND PL STRAIG 6HO T1.5 TI; MATMAND SCR Ø2 SELF-TAP L5 TAN 1U I/CLIP; MATMAND SCR Ø2.4 SELF-TAP L6 TAN 1U I/CL; MATRIXMAND MINI-TENSIONPL NARROW CENTRE