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

Model Number 388.72

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Investigation summary customer quality investigation: the device was not returned.A photo-investigation was performed on the image.Upon inspecting the image provided, it was observed that the distal tip of the cutting edge of the device was broken.However, the root cause of the breakage cannot be determined based on the available image.No other issues were noted.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history review a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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 synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the cutter blade on the large pin cutter is chipped.It was unknown that how it happened.The procedure and patient outcome were unknown.This complaint involves one (1) device.This report is for (1) rod cutter this report is 1 of 1 for (b)(4).

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 number: 388.72, lot number: 83p5220, manufacturing site: tuttlingen, release to warehouse date: 17-feb-2021.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Visual inspection: the rod cutter (part #: 388.72, lot #: 83p5220) was returned and received at us customer quality (cq).Upon visual inspection of the device and the picture, it was observed that the distal tip of the cutting edge of the device was broken.The broken fragments were not returned.No other issues were identified with the returned device.Service & repair evaluation: the customer reported cutter blade on the large pin cutter is chipped.The repair technician reported the jaw is broken and piece is missing.Cutting jaws broken is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed rod cutter.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the rod cutter (part #: 388.72, lot #: 83p5220).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.

• 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
• MDR Report Key: 12059048
• MDR Text Key: 258163672
• Report Number: 2939274-2021-03192
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10705034773759
• UDI-Public: (01)10705034773759
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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: 83P5220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Date Manufacturer Received: 07/26/2021
• Patient Sequence Number: 1