MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM; SCREW, FIXATION, BONE

Catalog Number 04.210.120

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is j&j field sales assistant.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, it was identified that the packaging of a variable angle locking screw was empty and yet sealed.It was a part of the stock room cabinet.There was no patient involvement.This report is for one (1) 2.4mm ti va locking screw stardrive 20mm.This is report 1 of 1 for complaint (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.Manufacturing location: monument; manufacturing date: september 12, 2018; part: 04.210.120, 2.4mm ti va locking screw stardrive 20mm; lot: h731269 (non-sterile); lot quantity: 204.Work order traveler met all inspection acceptance criteria.Inspection sheet, mill shaft thread / head thread / flute, met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.There is no indication in the device history record (dhr) that any of the packages were identified as empty.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 ¿empty package¿ does not indicate breakage of the screw.Therefore, review of the component part dhrs would not be relevant to the reported complaint condition.Flow: labeling &packaging.The package was not physically returned for this investigation.The investigation was requested to be based on a photograph provided of the allegedly empty package.Visual inspection: the photo indicates that the package has the correct lot number and part number relevant to the reported complaint.The photo shows the label side of the package only.Visually, the package appears to be sealed as is indicated by the complaint, however, because the label obscures the interior view of the package, it could not be determined whether the package was, indeed, empty.Additionally, due to granularity and glare on the photograph, it could not be confirmed whether there were any small holes in either the perforated or sealed seams of the package.The manufacturing record evaluation was reviewed, and all parts were indicated to have been packaged and labeled.The complaint is not confirmed.Dimensional inspection and document/ specification review: due to the nature of the complaint, it could not be performed.Manufacturing record evaluation showed 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.Investigation conclusion: the investigation, as based on the photographic evidence provided, was unable to confirm the reported complaint condition of a sealed, empty package.The results of this investigation are unconfirmed from a manufacturing perspective.Should the package be physically returned, further investigation will be conducted.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8573316
• MDR Text Key: 143849092
• Report Number: 8030965-2019-63381
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819980259
• UDI-Public: (01)07611819980259
• Combination Product (y/n): N
• PMA/PMN Number: K103243
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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: H731269
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2019
• Patient Sequence Number: 1