MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MAXFRAME(TM) RADIOGRAPHIC MARKER; APPLIANCE,FIXATION,NAIL

Model Number 03.312.840

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device was 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 Description

It was reported that on an unknown date, the maxframe (tm) radiographic marker was broke while being washed during sterilization process.There was no patient involvement.This report is for one (1) maxframe(tm) radiographic marker.This is report 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 03.312.840, lot h226940: release to warehouse date: march 27, 2017.Manufactured by synthes brandywine.No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.H3, h6: a product investigation was completed: visual inspection performed revealed that the component was broken with the top four millimeters (4mm) missing, and the maxframe radiographic marker cap was missing from the assembly because it broke off with the housing.Dimensional inspection was not performed due to the post manufacturing damage.The current and manufactured to drawings were reviewed.Device history record (dhr) performed revealed that the product passed all inspection criteria and no nonconformance related to the complaint condition were present for the complainant lot.This complaint is confirmed as the device was returned broken.No definitive root cause could be determined based on the provided information, but the investigation revealed that this was not due to a manufacturing process.It is likely that the device experienced excessive forces during usage that cause it to fail.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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: MAXFRAME(TM) RADIOGRAPHIC MARKER
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10861028
• MDR Text Key: 216921454
• Report Number: 2939274-2020-05206
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982260956
• UDI-Public: (01)10886982260956
• Combination Product (y/n): N
• PMA/PMN Number: K161417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.312.840
• Device Catalogue Number: 03.312.840
• Device Lot Number: H226940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 12/11/2020
• Patient Sequence Number: 1