MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

Model Number	399.091
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981); Mechanical Jam (2983)
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: 399.091, synthes lot number: t923252, release to warehouse date: 06/06/2008, manufacture site: (b)(4), part expiration date: n/a, list of nonconformance¿s: n/a.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.No ncrs were generated during the production of this device.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A product investigation was conducted.Visual inspection: visual inspection of the returned device revealed the pivot screw's laser weld was broken.No other damage was noted any other feature of the device.The screw was slightly loose, causing a looseness between the two levers.The synthes-(b)(4) repair technician noted the forceps' tips were bent.The condition was not observed during cq investigation and the bent condition was not confirmed.Functional test: with several attempts of opening and closing, the device experienced intermittent misalignment of the forceps' tips when fully closed.The device was difficult to open from the fully closed state.The received condition agreed with the complaint description of misalignment and jamming.The complaint was replicated with the returned device.Dimensional inspection: dimensional inspection is not relevant to the malfunction, as the loose received condition of the levers and screw was attributed to the pivot screw's broken laser weld.Document/specification review: the relevant drawings were reviewed during investigation: sustaining engineering ticket was launched due to the observed unaddressed design changes to the screw and handle components at their interfacing features.The us source control drawing was updated to reflect the device's ous manufactured-to drawing.No change was made to the device's design.The change had no impact to the manufacturing of the device.Ticket was appropriately addressed and closed.No design issues were observed.Dhr review: review of the device's dhr files revealed no relevant issues during the manufacture of this device.The device was manufactured in 2008.A material review is not relevant to the failed laser weld.Conclusion: the complaint was confirmed with investigation.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 on an unknown date during sterilization and inspection, the jaw part of a bone holding forceps was found out not aligning or closing properly and does not clamp down all the way.It was noted that the instrument was difficult to use and the mechanism sticks.There was no patient and procedure involvement.This report is for one (1) bone holding forceps-soft ratchet f/plates to 9mm wide.This is report 1 of 1 for complaint (b)(4).

• Brand Name: BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8325545
• Report Number: 2939274-2019-56384
• Device Sequence Number: 16632889
• Product Code: HTD
• UDI-Device Identifier: 10886982202314
• UDI-Public: (01)10886982202314
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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
• Type of Report: Initial
• Report Date (Section B): 12/14/2018

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: 399.091
• Device Catalogue Number: 399.091
• Device Lot Number: T923252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1