MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM; PLATE, BONE

Catalog Number 04.503.408.01C

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer 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 russia reports an event as follows: it was reported that during acceptance of the goods, a non-conformance was detected in the quantities of the products included.The package contains two self-tapping screws.This report is for a matmand scr ø2 self-tap l8 tan 1u i/clip.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: photo investigation: visual analysis of the returned sample was performed on matmand scr ø2 self-tap l8 tan 1u i/clip.During the acceptance of the goods, a nonconformance was found in the quantities of products in the package.The package contains two self-tapping screws and both are in containers.Per the complaint and accompanying photographic evidence, the complaint condition was confirmed as a non-sterile packaging with missing product.The dimensional inspection was not performed since the product was not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the matmand scr ø2 self-tap l8 tan 1u i/clip.The root cause of the complaint condition can be confirmed due to the manufacturing issue.The received condition of the matmand scr ø2 self-tap l8 tan 1u i/clip confirmed that the quantity of the package was incorrect.Jabil monument initiated non-conformance (nc): to further evaluate and determine the manufacturing error in detail that led to the complaint condition.Any further actions will be determined under jbl-nr opened at jabil monument.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument manufacturing date: 02-feb-2022 part number: 04.503.408.01c, 2.0mm ti matrixmandible screw self-tapping 8mm lot number: 629p016 (non-sterile) lot quantity: (b)(4) production order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection, met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.A total of 121 labels were printed.119 labels were placed on product; 1 label on the pll and 1 label was destroyed.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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: component parts were not reviewed as the reported complaint condition of ¿package contained two screws and both were in containers¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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: 2.0MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380
• MDR Report Key: 14429936
• MDR Text Key: 291946675
• Report Number: 8030965-2022-03277
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 07611819925021
• UDI-Public: (01)07611819925021
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K063790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.503.408.01C
• Device Lot Number: 629P016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1