MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM; RETRACTOR

Model Number	03.100.018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part number: 03.100.018, lot number: t981488, manufacturing site: (b)(4), release to warehouse date: 17-jul-2012.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.A product investigation was conducted.Visual inspection: visual inspection was performed on received device (part# 03.100.018, lot#t981488 , mfg# 17-jul-2012) showed that the tip of the ball spike was found broken and bent.There is a slight deformation of material at the tip which matches with the complaint condition.Minor surface ware was noticed on the handle.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly deformed due to post-manufacturing damage.Document specification review: the relevant document were reviewed(both current and time of manufacturing) the overall complaint is confirmed.Conclusion: a definitive root cause for the device breakage could not be determine it is possible that the device encountered unintended forces (during usage) that led to observed condition.The overall complaint condition is confirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 an unknown date, the straight ball spike for low profile pelvic system was broken/bent.There was no patient involvement.This report is for one (1) straight ball spike for low profile pelvic system.This is report 1 of 1 for complaint (b)(4).

• Brand Name: STRAIGHT BALL SPIKE FOR LOW PROFILE PELVIC SYSTEM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8656043
• Report Number: 2939274-2019-58392
• Device Sequence Number: 11380904
• Product Code: GAD
• UDI-Device Identifier: 10886982070678
• UDI-Public: (01)10886982070678
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 03.100.018
• Device Catalogue Number: 03.100.018
• Device Lot Number: T981488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1