MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TABLE TOP ROD CUTTER AND BENDER; CUTTER, SURGICAL

Model Number	388.750
Medical Device Problem Codes	Mechanical Problem (1384); No Fail-Safe Mechanism (2990)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.The tabletop rod cutter and bender (p/n: 388.750, lot #: 5l78577) was returned and received at us cq.Upon visual inspection, it was observed that the handle component 388.750.001 and the operating lever with handle were missing from the device.The cap nut component and the teflon washer component were disassembled from the set screw dia 35 component.The distal threads of the set screw were observed to be deformed and the teflon washer was cut.The missing components were designed to be disassembled by the user.The components being missing from the device and the damage on the set screw and nut do not contribute towards the complaint condition.No other issues were identified with the returned device.The complaint condition was confirmed for the tabletop rod cutter and bender (p/n: 388.750, lot #: 4l59395).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 and for missing components, it could be due to device maintenance or device incorrectly assembled during the sterilization process.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 history lot, part number: 388.750.Lot number: 5l78577, manufacturing site: (b)(4).Release to warehouse date: 09.Aug.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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
It was reported that on (b)(6) 2020, the end joint of table top rod cutter and bender has become to stiff to properly function.Cutter arm will no longer freely open and close.It is unknown if there was a surgical delay.Procedure outcome is unknown.No patient consequence.This report is for one (1) table top rod cutter and bender.This is report 1 of 1 for (b)(4).

• Brand Name: TABLE TOP ROD CUTTER AND BENDER
• Common Device Name: CUTTER, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10665250
• Report Number: 2939274-2020-04613
• Device Sequence Number: 3456940
• Product Code: FZT
• UDI-Device Identifier: 10705034773766
• UDI-Public: (01)10705034773766
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 388.750
• Device Catalogue Number: 388.750
• Device Lot Number: 5L78577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1