MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STAND FOR ALIGNMENT ROD; GUIDE

Model Number	03.108.031
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a synthes employee.Part: 03.108.031 lot: 3l25993 manufacturing site: (b)(4).Release to warehouse date: january 30, 2019 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the stand for alignment rod was returned and received at us customer quality (cq).Upon visual inspection, the internal threads of the device were fine, but the edge of the alignment rod insertion opening was observed to be slightly deformed.No other issues were identified with the returned device.Functional test: a functional test was not performed as the device was returned by itself.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.Stand with handle investigation conclusion the complaint condition is confirmed for the stand for alignment rod.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
It was reported that during routine incoming inspection of a loaner set on an unknown date, the stand for alignment rod was non-functional.There was no patient and surgical involvement.Upon manufacturer investigation, it was observed that the edge of the alignment rod insertion opening was slightly deformed.This report is for a stand for alignment rod.This is report 1 of 1 for (b)(4).

• Brand Name: STAND FOR ALIGNMENT ROD
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11233041
• Report Number: 2939274-2021-00497
• Device Sequence Number: 19673129
• Product Code: FZX
• UDI-Device Identifier: 10886982071729
• UDI-Public: (01)10886982071729
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 03.108.031
• Device Catalogue Number: 03.108.031
• Device Lot Number: 3L25993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1