MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH POLY SCREW DRIVER RETEN SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 2020-00-401

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device was received, 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

It was reported that on (b)(6) 2020, the symphony screwdriver jammed inside holding sleeve.The set used for the surgery contains three screwdrivers.The other two working screwdrivers were used to implant screws.There was no surgical delay.There was no patient consequence.Procedure and patient outcome are unknown.This report is for one (1) poly screw driver reten sleeve.This is report 2 of 2 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.Investigation summary: visual inspection: the poly screw driver reten sleeve (p/n: 202000401, lot number: pc4895142 ) was received at us cq.Visual inspection of the complaint device showed no damage to the device.The device was received disassembled from the mating device ((b)(4)).Functional test: a functional assessment was performed on the complaint device and the returned mating device.The devices were difficult to partially assemble and then difficult to disassemble.However, this was due to damage on the mating device.The complaint was able to be replicated.Dimensional inspection: drawing: specified dimensions: shaft inner diameter = measured dimensions: shaft inner diameter = conforming.Device used - gauge pins gp32.Document/specification review: 103234729 rev d (current) and rev c (manufactured) were reviewed.103234732 rev c (current) and rev b (manufactured) were also reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes - since there is a functional issue even though the complaint device is non-defective.Investigation conclusion: this complaint is confirmed since there is difficulty assembling and disassembling.However, this is due to the damage on the mating device, and the complaint device has no damage and has conforming measurements.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 screw driver reten sleeve was conducted identifying that lot number pc4895142 was released in a single batch.Batch1: lot was released on jul 24, 2019 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 SCREW DRIVER RETEN SLEEVE
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10985094
• MDR Text Key: 220717148
• Report Number: 1526439-2020-02390
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034532776
• UDI-Public: (01)10705034532776
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2020-00-401
• Device Catalogue Number: 202000401
• Device Lot Number: PC4895142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: POLY SCREW DRIVER SHFT X20; POLY SCREW DRIVER SHFT X20