MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; SCREW, FIXATION, BONE

Model Number 02.211.020

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Initial reporter is a synthese employee.Manufacturing location: monument.Manufacturing date: 29-mar-2022.Part number: 02.211.020, 2.7mm va lckng screw slf-tpng with t8 stardrive recess 20mm lot number: 745p369.Lot quantity: (b)(4).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 ¿empty package¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.The product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Note: following investigation was performed by jabil.The product was returned to depuy synthese for evaluation.The depuy synthese team forwarded photographs of the device to jabil where a visual inspection of the device was conducted.The affected part was not returned.Visual analysis of the photographic evidence revealed that the va locks 2.7 head 2.4 self-tap l20 was missing from the sealed packaging.The package appears to have not been sealed.From the packaging bill of materials (som), this device utilized non-sterile packaging that comes in a roll-stock and is fed into the sharp bagger machine.The perforations on the open end of the pouch attach to the perforations on a second pouch directly to the right of the supplier seal.Reviewing the provided picture, there does not appear to be a seal created on this package.A review of the ohr was completed.This was processed on (b)(6) 2022.A review of the maintenance work orders was completed and no tickets or work orders were created on this date.Furthermore, the packaging label log {pll} was reviewed for accuracy.While the label reconciliation was completed correctly, it was noted that there were 7 extra labels in the order that were scrapped.There is evidence to suggest that one of these 7 labels was placed on a pouch and delivered with the remaining order.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the empty package would contribute to the complained device issue.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.

Event Description

Device report from belgium reports an event as follows: it was reported that on (b)(6) 2022, the product in question was found with empty packaging.The event occurred pre-op, there was no reported patient interaction.No further information was provided.This report is for a 2.7mm va lckng screw slf-tpng with t8 stardrive recess 20mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• Type of Device: SCREW, FIXATION, 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 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16452417
• MDR Text Key: 310353466
• Report Number: 8030965-2023-02417
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982053619
• UDI-Public: (01)10886982053619
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.211.020
• Device Catalogue Number: 02.211.020
• Device Lot Number: 745P369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1