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 Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records has been requested.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 a metatarsophalangeal joint fusion procedure on (b)(6) 2019, the ratchet part of the compression forceps did not operate and will not hold compression.The surgeon had to manually continue to hold the pressure instead of using the forceps.Fragments were generated and was successfully removed.There was no surgical delay.Surgery was successfully completed.No unanticipated x-rays were needed.The patient and procedure outcome are unknown.This report is for one (1) compression forceps.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: a device history record (dhr) review was conducted: part number: 03.211.400, synthes lot number: t961228, release to warehouse date: 04-may-2011, manufacture site: tuttlingen, 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.The raw material certificate was reviewed and the used material was according to the specification of the device.No non-conformance reports (ncrs) were generated during the production of this device.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.H3, h6: a product investigation was conducted.Visual inspection: visual inspection of the returned forceps revealed the ratcheting rail component¿s teeth were worn and rounded.The flap component was chipped at the feature that interfaces with the ratcheting rail teeth.The balance of the device was undamaged.No feature or component was found to be broken.Functional test: the forceps were not able to lock/hold position.A moderate application of force was able to open the forceps when the flap engaged with the ratcheting rail teeth.Conclusion: the complaint was confirmed during investigation.After a visual inspection per guidance provided, it is determined that the reusable instrument device is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During investigation, no product design or manufacturing issues were observed that may have contributed have contributed to the complaint condition; therefore, further corrective and/or preventative 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• 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: 8293489
• Report Number: 2939274-2019-56178
• Device Sequence Number: 1620694
• Product Code: HWN
• UDI-Device Identifier: 10886982076267
• UDI-Public: (01)10886982076267
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 01/11/2019

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: 03.211.400
• Device Catalogue Number: 03.211.400
• Device Lot Number: T961228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/28/2019; 03/07/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 03/05/2019; 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 111