MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CHISEL BLADE 10MM; CHISEL, SURGICAL INSTRUMENT

Model Number	399.55
Medical Device Problem Codes	Break (1069); Failure to Cut (2587); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, one (1) chisel blade w/ 10, one (1) chisel blade w/ 16 and one (1) periosteal elevator 6mm curved blade - straight edge were marked as broken in medical device reprocessing department (mdrd).The tip of the two (2) chisel blades were uneven and dull.The tip of the periosteal elevator was dinged and dull.There was no patient and procedure involvement.This report is for one (1) chisel blade 10mm.This is report 1 of 3 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.The device was received.Device history.Part number: 399.550, synthes lot number: t168610, release to warehouse date: 25-may-2018, manufacture site: tuttlingen, part expiration date: n/a, list of non-conformance¿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.Traceability to the raw material lot number could not be established during this dhr review.No ncrs were generated during the production of this device.Device history batch null, device history review 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.Investigation summary complaint description: it was reported that on an unknown date, one (1) chisel blade w/ 10, one (1) chisel blade w/ 16 and one (1) periosteal elevator 6mm curved blade - straight edge were marked as broken in medical device reprocessing department (mdrd).The tip of the two (2) chisel blades were uneven and dull.The tip of the periosteal elevator was dinged and dull.There was no patient and procedure involvement.Flow: damage: visual (appearance not as expected.Visual inspection: the returned device was examined, and the distal cutting edge was found to be dull and deformed; the device was not found to be broken.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.No further visual defects or deficiencies were noted.Conclusion: after a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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.

• Brand Name: CHISEL BLADE 10MM
• Common Device Name: CHISEL, SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8254988
• Report Number: 2939274-2019-55900
• Device Sequence Number: 1946886
• Product Code: FZO
• UDI-Device Identifier: 10886982202901
• UDI-Public: (01)10886982202901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 399.55
• Device Catalogue Number: 399.550
• Device Lot Number: T168610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1