MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH MATRIX LOCK SCREW Ø1.85 SELF-DRILL L6 TA; SCREW, FIXATION, BONE

Catalog Number 04.511.666.04S

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/03/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.It is unknown if the other screws the package were implanted during the procedure.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 review of the device history records 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2018 during a maxillary osteotomy to fix maxilla plate there were only three (3) screws packed in the brand-new package when opened; there should have been four (4).The surgeon searched for the missing screw, but the surgeon could not find it.The surgery was finished without any other problem.The surgery was completed successfully.There were no surgical delay and adverse consequence to the patient reported.This is report 1 of 1 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.Device history records review was completed for part: 04.511.666.04s, lot: l942708.Manufacturing location: selzach, release to warehouse date: jun 21, 2018, expiry date: jun 01, 2028.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all packaging criteria at the time of release with no issues documented during the manufacturing process.Non-sterile part 04.511.666.04c / h550292 was manufactured in us, monument.Manufacturing date: jan 24, 2018.Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Pll indicates that parts were packaged four pieces per bag.There is no indication in the dhr that one piece was missing from any package.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.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Product investigation was completed.Visual inspection: the matrix locking screws ø 1.85 self-drilling was received with one of the screws missing from the pack of four.The complaint is confirmed for a missing screw however, it cannot determine when the screw went missing since the packaging was returned opened.Document/specification review: relevant drawing was reviewed.The production papers were checked and there was no recorded deviation with the production.The products are shipped pre-assembled to früh.The incoming inspection at früh's was performed by counting the delivered packs.Therefore, there is no inspection if all delivered parts are complete in terms of missing components.As the counting of the pre-assembled parts are performed and the amount was correct the order was proceeded as planned.Package was returned for evaluation and examined.There is one screw missing from the 4 pack clip assembly.Package was no longer in the original depuy synthes packaging and the lot number has been changed.Product has been packaged in a sterile pack configuration and relabeled with a sterile product part number and lot number.All packaging has been opened.A review of the manufacturing history for the original lot (h550292) part does not show any indication of a count discrepancy in which a part would have been missing from the lot.Additionally, the product has been removed from the original packaging, has been repackaged and relabeled and was returned opened.With all of this evidence combined it could not be determined that depuy synthes monument manufacturing was responsible for the missing product.The product has been removed from the original packaging, repackaged and opened again at some point.The complaint condition is confirmed as the matrix locking screw (part # 04.511.666.04s, lot # l942708) was received with one of the screws missing from the package.However, the complaint is unconfirmed for any design or manufacturing issues.No definitive root cause could be determined.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.The subject device has been 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.

• Brand Name: MATRIX LOCK SCREW Ø1.85 SELF-DRILL L6 TA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7906393
• MDR Text Key: 121714281
• Report Number: 8030965-2018-56628
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819386600
• UDI-Public: (01)07611819386600
• Combination Product (y/n): N
• 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: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.511.666.04S
• Device Lot Number: L942708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Date Manufacturer Received: 11/30/2018
• Patient Sequence Number: 1