MAUDE Adverse Event Report: SYNTHES GMBH 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM; PLATE, BONE

Catalog Number 04.511.206.01S

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/04/2021

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 the mandible and maxilla osteotomy, the surgeon had difficulty connecting the matrix screw and an unknown screwdriver.The tip of the screwdriver was not able to be put in the screw thread.Patient outcome is reported as stable.No further information is available.This report is for one (1) 1.85mm ti matrix screw self-tapping/6mm this is report 1 of 2 for complaint (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.The product was returned to depuy synthes for evaluation.Depuy synthes cq conducted visual inspection of the returned device.Dimensional inspection was not performed as there was no evidence of damage.Visual analysis of the returned sample revealed that no damage were observed on the matrix screw ø1.85 self-tap l6 tan 1u.As part of depuy synthes's quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the matrix screw ø1.85 self-tap l6 tan 1u was returned without any damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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.Device history lot : sterile part part: 04.511.206.01s, lot: l932352, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 13.June 2018, expiry date: 01.June 2028.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non-sterile part.Part: 04.511.206.01c, lot: h631660.Manufacturing location: monument manufacturing date: 02-may-2018, part number: 04.511.206.01c, 1.85 mm ti matrix screw self-tapping/6mm, lot number: h631660 (non-sterile).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, tialnbr14.00, lot number: h511969.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.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/6MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11653209
• MDR Text Key: 247567695
• Report Number: 8030965-2021-02799
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819362215
• UDI-Public: (01)07611819362215
• 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: 03/15/2021

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: 04.511.206.01S
• Device Lot Number: L932352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/26/2021
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS: CMF