MAUDE Adverse Event Report: DEPUY SPINE INC 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 01/03/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).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.Additional narrative: additional pro-code: olo.Initial reporter occupation: reporter is a j&j sales representative.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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

It was reported that on january 3, upon routine inspection deficiencies were noted with both symphony screw drivers and drill guides: 2x screw driver shafts difficult to insert and then freezing inside driver retention sleeve in spite of numerous cleaning and lubrication.2x symphony drill guide adjustables difficult to insert and then locking up inside the guide body in spite of numerous cleaning and lubrication.There were no patient outcomes/consequences.There were no patient involvement.This complaint involves four (4) devices.This report is for one (1) poly screw driver reten sleeve.This is report 4 of 4 for complaint.

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: a review of the receiving inspection (ri) for poly screw driver reten sleeve was conducted identifying that lot number pc4907027 was released in one batch.Batch 1: lot qty of (b)(4) units were released on 12 aug 2019 with no discrepancies supplier: greatbatch medical 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this 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): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16230402
• MDR Text Key: 309090387
• Report Number: 1526439-2023-00110
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034532776
• UDI-Public: (01)10705034532776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Model Number: 2020-00-401
• Device Catalogue Number: 202000401
• Device Lot Number: PC4907027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2023
• Initial Date FDA Received: 01/23/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ADJ DRILL GUIDE BODY 2.2-2.4MM; ADJ DRILL GUIDE BODY 2.2-2.4MM; ADJ DRILL GUIDE BODY 2.8MM; ADJ DRILL GUIDE BODY 2.8MM; POLY SCREW DRIVER RETEN SLEEVE; POLY SCREW DRIVER SHFT X20; POLY SCREW DRIVER SHFT X20