MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK

Model Number	399.051
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device history records review not available for reporting at this time.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 surgery a pair of reduction forceps broke.All the pieces were retrieved from the patient.There was no harm to the patient.This complaint involves one (1) part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part 399.051, lot t937684: release to warehouse date: july 10, 2009.Manufacture site: tuttlingen.A review of the device history records (dhr) showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No non-conformance reports (ncrs) were generated during the production of this device.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Initially reported as march 28, 2018; should have been march 27, 2018.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 surgery on march 27, 2018 the surgeon noticed, after fixation, that the tip of a pair of reduction forceps broke off.All the pieces were retrieved from the patient with no additional medical intervention.There was no harm to the patient and no surgery delay.The patient condition was reported as stable.

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW 240MM-SPEED LOCK
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7440658
• Report Number: 2939274-2018-51805
• Device Sequence Number: 1055130
• Product Code: HTD
• UDI-Device Identifier: 10886982202253
• UDI-Public: (01)10886982202253
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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: 399.051
• Device Catalogue Number: 399.051
• Device Lot Number: T937684
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR