MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD CUTTER; CUTTER, WIRE

Model Number 03.614.021

Device Problem Material Integrity Problem (2978)

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

Event Date 11/27/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown spinal procedure, the tip of the rod cutter broke during use.The cutting was performed on a side table so no fragments went into the patient.The procedure was completed using another unknown rod cutter.There was no patient consequence.The procedure outcome and surgical delay are unknown.This report is for (1) rod cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

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.H3, h4, h6: part: 03.614.021 lot: a7qa37 manufacturing site: tuttlingen release to warehouse date: september 19, 2007 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Review of raw material certificate could not be established during this review due to the age of the device.Visual inspection: the rod cutter was received at us customer quality (cq).Visual inspection of the complaint device showed that one of the jaws of the device had broken off and the broken fragment was not returned.No other issues were observed with the complaint device.Dimensional inspection: a relevant dimensional inspection was not able to perform on the complaint device due to the device geometry.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed rod cutter assembly no design issues or discrepancies were identified.Investigation conclusion: this complaint was confirmed as the device was received with a broken jaw.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 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: ROD CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13118457
• MDR Text Key: 284723084
• Report Number: 2939274-2021-07276
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10705034714929
• UDI-Public: 10705034714929
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.614.021
• Device Catalogue Number: 03.614.021
• Device Lot Number: A7QA37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2007
• 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: UNK - SCREW/ROD CONSTRUCT ACCESSORIES