MAUDE Adverse Event Report: SYNTHES GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM; BONE PLATE

Catalog Number 04.511.205.01S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j 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

It was reported that this was a maxillar-device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery of maxillar-mandibule osteotomy.During the surgery, the matrix midface was applied in the maxillary side and moj was applied in the mandibular side.But the screw was not able to be attached to the contra angle driver (unk).The surgery was completed without delay.The patient outcome was unknown.No further information is available.This complaint involves two (2) devices.This report is for (1) 1.85mm ti matrix screw self-tapping/5mm.This report is 1 of 2 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: part: 04.511.205.01s, lot: 6l70272, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 17 february 2020, expiration date: 01 february 2030.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part: 04.511.205.01c, lot: 25p0825.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that matrix screw ø1.85 self-tap l5 tan 1u i the threads of the screw were slightly deformed, and no other issues were identified.The dimensional inspection was not performed for the matrix screw ø1.85 self-tap l5 tan 1u i/ due to post manufacturing damage.The functional test was not performed since the device was received by itself but the alleged unable to assemble condition can be confirmed since the threads of the screw were deformed which might be the reason for the complaint condition.The observed unable to assemble of the components is consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for matrix screw ø1.85 self-tap l5 tan 1u i/.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: 1.85mm orthognathic self-tapping screw matrix orthognathic 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.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.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: 1.85MM TI MATRIX SCREW SELF-TAPPING/5MM
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12333054
• MDR Text Key: 266956234
• Report Number: 8030965-2021-06758
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819362192
• UDI-Public: (01)07611819362192
• Combination Product (y/n): N
• PMA/PMN Number: K083388
• 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: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.205.01S
• Device Lot Number: 6L70272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/16/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: CMF; UNK - SCREWDRIVERS: CMF