MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STRAIGHT/CURVED POINTED REDUCTION FORCEPS

Model Number	03.117.998
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes sales consultant.Part 03.117.998, lot t108066: manufacturing site: (b)(4).Release to warehouse date: november 13, 2014.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 completed: the instrument was received broken at the spindle, in addition the spindle is bent preventing the speed nut from advancing.The balance of the device is in fair condition.A dimensional inspection of features relevant to this complaint could not be obtained due to post manufacturing damage and the spindle was cut on purpose as stated in the complaint description.The relevant documents were reviewed as part of this investigation.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The root cause could not be definitively determined to why the nut became stuck, the broken condition of the instrument was due to the surgeon cutting the spindle in order to remove the instrument from the patient.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 on (b)(6) 2019, the patient underwent an elbow surgery when the spin down nut got stuck of the straight/curved pointed reduction forceps on thread.Surgeon had to cut the thread to allow the clamp to be removed from the patient.Procedure was successfully completed with a minimal delay of one (1) minute.There were no fragments generated.Patient status was unknown.The instrument was received broken at the spindle, in addition the spindle is bent preventing the speed nut from advancing.This report is for a reduction forceps.This is report 1 of 1 for (b)(4).

• Brand Name: STRAIGHT/CURVED POINTED REDUCTION FORCEPS
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8744013
• Report Number: 2939274-2019-58907
• Device Sequence Number: 16564219
• Product Code: HTD
• UDI-Device Identifier: 10886982073297
• UDI-Public: (01)10886982073297
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• 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: 03.117.998
• Device Catalogue Number: 03.117.998
• Device Lot Number: T108066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR