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

Model Number	388.72
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CUTTER, WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10631632
• Report Number: 2939274-2020-04499
• Device Sequence Number: 3205443
• Product Code: HXZ
• UDI-Device Identifier: 10705034773759
• UDI-Public: (01)10705034773759
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1