MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION FORCEPS; INSTRUMENT COMPRESSION

Model Number	03.211.400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history records review was completed for part# 03.211.400, lot# t950802.Manufacturing location: (b)(4), release to warehouse date: jan 28, 2011.A review of the device history records showed that there were no issues at the time of manufacturing of this device and it's sub components that would contribute to the complaint condition.The raw material certificate was reviewed and the used material was according to the specification of the device.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed.Upon inspection it was noticed that a piece of the small flap had chipped off and contributed to the complaint condition.Functional test was able to replicate the complaint condition.It is likely that over seven years of routine use contributed to the piece of the small flap chipping off.Due to post-market damage, and the damaged area being to small to access, an effective dimensional inspection could not be performed.Relevant drawings were reviewed during investigation, and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.Although a definitive root cause could not be determined, it is most likely that the complaint condition is due to routine use/processing over its over seven-year lifespan, and/or rough usage.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Therefore, it has been determined that no corrective and/or preventive 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 a returned compression forceps from fsl facility was noted as ¿not locking¿.The device was inspected as part of the routine incoming inspection on (b)(6) 2018.The forceps was being out of specification.There was no patient or hospital involvement.Upon inspection it was noticed that a piece of the small flap had chipped off and contributed to the complaint condition.This report is for one (1) compression forceps.This is report 1 of 1 for (b)(4).

• Brand Name: COMPRESSION FORCEPS
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7929755
• Report Number: 2939274-2018-54113
• Device Sequence Number: 19169013
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/10/2018

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: 03.211.400
• Device Catalogue Number: 03.211.400
• Device Lot Number: T950802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1