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 Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2021, during a case the rod cutter handle broke when sizing rod for patient.The account had another rod cutter that was used to size the rod.Surgery was not delayed.The event did not have an impact on the surgery.There was no patient consequence.Concomitant devices reported: rod (part number unknown, lot unknown, quantity 1).This report involves one (1) table top rod cutter and bender.This is report 1 of 1 for (b)(4).
Additional 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, h6: investigation summary : investigation flow: damage.Visual inspection: the table top rod cutter and bender (p/n: 388.750, lot #: 1657576) was returned and received at us cq.Upon visual inspection, it was observed that the handle was observed to be broken and not returned.The screw used to assemble the handle to the operating lever was returned broken.There were scratches and discoloration observed on the device but have no impact on the device functionality.No other issues were observed with the returned device.The device failure/defect was identified.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.The complaint was confirmed.The device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the table top rod cutter and bender (p/n: 388.750, lot #: 1657576).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 history lot: part: 388.750, lot: 1657876, manufacturing site: umkirch, release to warehouse date: march 26, 2007.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.

• 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: 11266364
• Report Number: 2939274-2021-00618
• Device Sequence Number: 3302623
• Product Code: FZT
• UDI-Device Identifier: 10705034773766
• UDI-Public: (01)10705034773766
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 1657876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS
• Patient Age: 15 YR
• Patient Weight: 74