MAUDE Adverse Event Report: DEPUY SPINE INC APPROXIMATOR FC SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 279712580

Device Problem Device Slipped (1584)

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

Event Date 04/20/2022

Event Type  malfunction  

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.Additional narrative: initial reporter's phone number : (b)(6).A product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that approximator fc sleeve had its handle fallen apart.The handle was returned for inspection.A functional test was performed on the approximator fc sleeve.The handle was able to be screwed back, but is still loose.A dimensional inspection for the approximator fc sleeve was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the approximator fc sleeve would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for approximator fc sleeve was conducted identifying that lot number nw238047 was released in three batches.    batch1: (b)(4).Supplier: depu : (b)(6).Batch2:(b)(4).Supplier: depuy : (b)(6).Batch3: (b)(4).Supplier: depuy : (b)(6).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 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 depuy synthes reports an event in germany as follows: it was reported that during a procedure on (b)(6) 2022, while removing the approximator from the clip, the handle came loose from the thread.There was no surgical delay and no patient impact.Surgery was completed successfully with a second instrument.Patient outcome is reported as good.This report is for one (1) approximator fc sleeve this is report 1 of 1 for complaint (b)(4).

• Brand Name: APPROXIMATOR FC 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 ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15079626
• MDR Text Key: 303806125
• Report Number: 1526439-2022-01263
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10705034199009
• UDI-Public: (01)10705034199009
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 279712580
• Device Catalogue Number: 279712580
• Device Lot Number: NW238047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male