MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WIRE CUTTER 220MM; CUTTER, WIRE

Model Number	391.93
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the wire cutter leaf spring was broken.No patient involvement was reported.This report is for one (1) wire cutter 220mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint #(b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: e1: reporters state: ontario h3, h4, h6: a review of the device history record.Device history lot part number: 391.93 lot number: 9201 a manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.H3, h6: investigation summary background: a customer has informed us that they have a synthes instrument 391.93 that the leaf spring has broken.See attached photo this complaint involves one (1) device.Investigation floe: damage visual inspection: the wirecutter lrg w/cantilever l220 (p/n: 391.93, lot #: 9201) was returned and received.Upon visual inspection, the leaf spring was broken.No other issues were identified with the returned device.Service and repair evaluation: the customer reported the device leaf spring has broken.The repair technician reported the device had a broken leaf spring.The damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is the damaged component.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review since the manufactured date was not identified, reflecting the current revision were reviewed wire cutter, large: se_388181, rev.B the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the wirecutter lrg w/cantilever l220 (p/n: 391.93, lot #: 9201).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: WIRE CUTTER 220MM
• Common Device Name: CUTTER, WIRE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9727284
• Report Number: 2939274-2020-00894
• Device Sequence Number: 11307615
• Product Code: HXZ
• UDI-Device Identifier: 10886982198440
• UDI-Public: (01)10886982198440
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2020

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: 391.93
• Device Catalogue Number: 391.93
• Device Lot Number: 9201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 03/13/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 02/26/2020; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1