MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIXMIDFACE SCREW SELF-TAPPING 10MM; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 04.503.210.01C

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.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 an unknown date the customer received the device package which was empty.No further information was provided.This report is for one ti matrixmidface screw self-tapping 10mm 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.H3, h4, h6- the returned packaging was received at cq zuchwil in a open condition (opened at the perforation).The matrixmidface screw holder (two parts) is in an dissembled condition and the screw is missing.This complaint is rated as confirmed but no manufacturing discrepancies were identified during this investigation.Since the package was received in open condition there is no evidence to support the allegation made in the complaint.The manufacturing record evaluation showed that this lot of 119 pieces was manufactured in september 2019 according to the specification.The parts conformed to dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.In addition, we are not aware of any other complaints for this article- and lot combination.No definitive root cause was able to be determined.We can only assume that the perforated packaging as well as the screw holder was opened by inadequately handling or during the transport way, the screw went missing prior to arriving at the hospital.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 : manufacturing location: monument, manufacturing date: 11-sep-2019, part number: 04.503.210.01c, ti matrixmidface screw self- tapping 10mm, lot number: 17l0596 (non-sterile), component part(s) reviewed: part number: 21015, tialnbri4.00, lot number: 3l33328.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by perryman company dated 08-may-2019 was reviewed and determined to be conforming.Lot summary report dated 28-may-2019 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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: TI MATRIXMIDFACE SCREW SELF-TAPPING 10MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10897790
• MDR Text Key: 241420296
• Report Number: 8030965-2020-09191
• Device Sequence Number: 1
• Product Code: DZL
• 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: 10/30/2020

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: 04.503.210.01C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/29/2020
• Patient Sequence Number: 1