MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VA LOCKSCR Ø2.4 SELF-TAP L20 TAN; SCREW,FIXATION,BONE

Catalog Number 04.210.120

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional procode: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

Device report from portugal reports an event as follows: it was reported on an unknown date that the hospital received a package intact, sealed and labeled but without any material inside.This report is for one (1) va lockscr ø2.4 self-tap l20 tan.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Initial reporter state: lisboa.A review of the device history record.Device history lot manufacturing location: monument.Manufacturing date: 16-aug-2019.Part number: 04.210.120, 2.4mm ti va locking screw stardrive 20mm.Lot number: 14l9107 (non-sterile).Lot quantity: 219.Five pieces were scrapped in cell at op #10, mill shaft threads, as set-up parts.Production order traveler met all inspection acceptance criteria apart from the five pieces noted.Inspection sheet, mill shaft threads / head thread / flute, met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac was reviewed and determined to be conforming.220 labels were printed; 219 labels were used on product and 1 label was used on the pll.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(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿package received empty, sealed and labeled without material inside¿ does not indicate breakage or malformation 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.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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.

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.Corrected data: awareness date reported on follow up 1 report as september 25, 2019 but should have been october 29, 2019.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: VA LOCKSCR Ø2.4 SELF-TAP L20 TAN
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9181640
• MDR Text Key: 191604164
• Report Number: 8030965-2019-69279
• Device Sequence Number: 1
• Product Code: HWC
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.210.120
• Device Lot Number: 14L9107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Patient Sequence Number: 1