MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB NON-LCKNG SCREW SELF-DRILLING/10MM; PLATE,FIXATION,BONE

Model Number 04.501.250.01

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 synthes employee.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 usa as follows: it was reported that on (b)(6) 2019, the unopened package was received empty.There was no patient involvement.This complaint involves one (1) device.This report is for one (1) 2.7mm ti matrixrib non-lckng screw self-drilling/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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: part: 04.501.250.01; lot: 4l53617; manufacturing site: grenchen; release to warehouse date: 18 june 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.Picture review: narrative (empty package) could be verified from provided pictures.The complaint description mentions that the customer received an empty package, the package was not returned for evaluation, only a picture was provided.Information and picture were forwarded to the manufacturing site for evaluation.Summary from manufacturing evaluation: the review of the device history record revealed that this matrixrib non-lock screw was manufactured in june 2019 with no relevant non-conformities reported.However, the empty package was not detected during the manufacturing process.Based on the investigation results, this complaint is rated as confirmed as well as valid.Based on the available picture, the received depuy synthes bag appears to be welded and empty as claimed by the customer.Relevant actions have been taken to address the issue.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: 2.7MM TI MATRIXRIB NON-LCKNG SCREW SELF-DRILLING/10MM
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9453633
• MDR Text Key: 193928155
• Report Number: 2939274-2019-62636
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10887587073439
• UDI-Public: (01)10887587073439
• Combination Product (y/n): N
• PMA/PMN Number: K190409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.501.250.01
• Device Catalogue Number: 04.501.250.01
• Device Lot Number: 4L53617
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• Patient Sequence Number: 1