MAUDE Adverse Event Report: SYNTHES GMBH MATRIX LOCK SCREW 1.85 SELF-TAP L5 TAN; BONE PLATE

Catalog Number 04.511.635.04S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during a sagittal split ramus osteotomy (ssro) procedure, one (1) 1.85mm ti matrix screw, one (1) 1.85mm ti matrix screw, and one (1) unknown cmf screwdriver were incompatible.The screws were unable to attach to the screwdriver.The procedure was completed using replacement devices.There was no surgical delay.There is no further information available.This report is for one (1) matrix lock screw ø1.85 self-tap l5 tan.This is report 2 of 3 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: the device was received, the investigation is in progress, 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.

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: investigation summary: the product was returned to us cq for evaluation.The us cq team forwarded the device to the manufacturer jabil monument.Visual analysis of the returned sample revealed that matrix lock screw ø1.85 self-tap l5 tan no visual issues were identified and features relevant to the complaint condition were found acceptable therefore the cause of the complaint condition is not a result of the manufacturing process.The dimensional inspection was not performed due to alleged complaint condition.The functional was not performed since the mating part was not returned for evaluation.The observed condition of matrix lock screw ø1.85 self-tap l5 tan in the device was not 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 not confirmed for matrix lock screw ø1.85 self-tap l5 tan.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Device history lot sterile: part #: 04.511.635.04s.Lot #: 7l70977.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: jan 04, 2021.Expiration date: jan 01, 2031.Non-sterile: part #: 04.511.635.04c.Lot #: 81p7796.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: dec 08, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: MATRIX LOCK SCREW 1.85 SELF-TAP L5 TAN
• Type of Device: BONE PLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12329360
• MDR Text Key: 266853377
• Report Number: 8030965-2021-06730
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819386365
• UDI-Public: (01)07611819386365
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2021

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: 04.511.635.04S
• Device Lot Number: 7L70977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 09/13/2021; 10/08/2021
• Supplement Dates FDA Received: 10/08/2021; 10/11/2021
• Patient Sequence Number: 1
• Treatment: MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/; MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/; UNK - SCREWDRIVERS: CMF; MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/; MATRIX SCREW Ø1.85 SELF-TAP L5 TAN 1U I/; UNK - SCREWDRIVERS: CMF