MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH POLY SCW DRIVER SHFT, CANNULTD

Model Number	286720000N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on an unknown date, as the scrub tech was setting the room up for the case he noticed the driver was missing the tip.The driver was removed from the field.There was no procedure or patient involvement.This report is for one (1) polyaxial screw driver shaft.This is report 1 of 1 for (b)(4).
Additional 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: corrected data: d1, d2, d4, d10, h3, h6.Updated data: d10, h4.Investigation summary visual inspection: the poly scw driver shft, cannultd (part # 286720000 / lot # ui193487) was received at us cq.The distal tip of the device was broken, no fragments were returned.There were surface scratches and nicks consistent with normal wear along the shaft of the device.The received condition was consistent with the complaint condition thus the complaint was confirmed.Device failure/defect identified? yes; distal tip was broken dimensional inspection: since the distal tip was broken, the diameter of the shaft adjacent to breakage was measured.Drawing(s) specified dimensions: tip diameter measured dimensions: tip diameter = confirming device(s) used: ca148p document/specification review: drawing(s) reviewed: (current); (manufactured) conclusion: the overall complaint was confirmed for the received poly scw driver shft, cannultd (part # 286720000 / lot # ui193487) as the distal tip of the device was broken.Although no definitive root-cause can be determined it is possible the device experienced unintended forces leading to the breakage.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot a review of the receiving inspection (ri) for poly scw driver shft, cannultd was conducted identifying that lot number ui193487 was released in a single batch.- batch1: lot was released on march 12, 2014 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: POLY SCW DRIVER SHFT, CANNULTD
• Common Device Name: DRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10626675
• Report Number: 1526439-2020-01878
• Device Sequence Number: 14251896
• Product Code: HWR
• UDI-Device Identifier: 10705034388526
• UDI-Public: 10705034388526
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286720000N
• Device Catalogue Number: 286720000
• Device Lot Number: UI193487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1