MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 5MM; SCREW FIXATION INTRAOSSEOUS

Catalog Number 04.503.205.01C

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter contact information is unknown.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 europe reports an event in (b)(6) as follows: during orthognathic surgery on (b)(6) 2018, the screw broke.The broken pieces were retrieved from the patient.Surgeon used a new screw to complete the procedure.Surgery was completed successfully.There was no adverse event to the patient reported.This report is for a titanium (ti) matrixmidface screw self-tapping 5mm.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Date returned to manufacturer.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.Product code, common device name additiona product codel: jey.510k 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

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.Item: 04.503.205.01c; lot: 9818602; rm: 7739249; manufacturing quantity: (b)(4); manufacturing date: may 29, 201; manufacturing location: monument; product was inspected and passed.There were no nonconformances (ncs) or reworks generated during the manufacture of this lot.Raw material was received from nf&m international, inc on july 05, 2014.Certificate of report, provided by nf&m international, inc, certifying material conforms to the requirements of the purchase order.Raw material receiving/putaway checklist indicates requirements were met and passed.No ncs or reworks were generated during the manufacture of this lot.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Investigation site: cq zuchwil; selected flow 5: broken.Visual investigation: a threaded shaft with broken off screw head was received for investigation.The length of the threaded shaft is 4mm.The threads on the shaft are damaged and worn.The screw head is broken in 4 portions.The received condition agrees with the complaint description and therefore the complaint is confirmed.Dimensional inspection: because of the existing damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.Document/specification review: the cause of the complained malfunction is a post-manufacturing caused breakage/damage on the device, therefore no drawing/specification review is required.Material review: raw material was received from nf&m international, inc on july 05, 2014.Certificate of report, provided by nf&m international, inc, certifying material conforms to the requirements of the purchase order.Raw material receiving/putaway checklist indicates requirements were met and passed.Investigation conclusion: based on the condition of the received product and the available poor information, a manufacturing conclusion cannot be presented.The device history review shows that the correct raw material was used, and the implant met fully to our specifications at the time of manufacturing.There were no issues that would contribute to this complaint condition.Hence the most appropriate root cause was mechanical overload.Based on the investigation findings, it has been determined that no corrective and/or preventative action is appropriate.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: TI MATRIXMIDFACE SCREW SELF-TAPPING 5MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7641786
• MDR Text Key: 112860081
• Report Number: 8030965-2018-54663
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 07611819908352
• UDI-Public: (01)07611819908352
• 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,Followup
• Report Date: 06/05/2018

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: 04.503.205.01C
• Device Lot Number: 9818602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 08/22/2018
• Supplement Dates FDA Received: 07/20/2018; 08/23/2018
• Patient Sequence Number: 1