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

Model Number 388.72

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Part: 388.72.Lot: t186215.Manufacturing site: (b)(6).Release to warehouse date: 09-mar-2020 (5 devices), 30-mar-2020 (10 devices) and 15-apr-2020 (5 devices) a review of the device history records was performed for the finished device lot number and no relevant nonconformances were detected.Visual inspection: the rod cutter was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the distal tip of the device was broken and the broken fragment was not returned.No other issues were identified with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Rod cutter.Investigation conclusion: the complaint condition was confirmed for the rod cutter.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.

Event Description

Device report from (b)(4) reports an event as follows: it was reported that during a procedure on (b)(6) 2020, the surgeon had to cut a stainless steel needle and damaged the distal tip of the rod cutter blades.The rod cutter had been recently purchased and was damaged the first time it was used.Procedure was completed successfully with no delay.There was no impact on the patient.Upon manufacturer investigation, it was determined that the device was broken.This report is for a rod cutter.This is report 1 of 1 for (b)(4).

• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10631632
• MDR Text Key: 210216329
• Report Number: 2939274-2020-04499
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10705034773759
• UDI-Public: (01)10705034773759
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 388.72
• Device Catalogue Number: 388.72
• Device Lot Number: T186215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1