MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0/2.4MM UNIV DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Model Number	323.204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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
It was reported that on an unknown date, during a routine inspection of field equipment, one of the plate cutters and drill guides were broken.There was no patient involvement.This report involves (1) 2.0/2.4mm univ drill guide.This is report 2 of 2 for (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: updated data: h2, h6.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.H10 additional narrative: d9 - date device returned to manufacturer.H6 - codes updated to imdrf codes.Service and repair evaluation: the customer reported the drill guide was broken.The repair technician reported the device was missing 2 springs and the 1.8mm drill sleeve.Missing component is the reason for repair.The cause of the issue was not determined.The following parts were replaced: compression spring and 1.8mm drill sleeve.The item was repaired per the inspection sheet, passed synthes final inspection on 26-oct-2021 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history lot - part #:323.204.Synthes lot #: 3974934.Release to warehouse date: 12 aug 1999.Manufactured by: brandywine.No ncr's generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: 2.0/2.4MM UNIV DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12710868
• Report Number: 2939274-2021-06343
• Device Sequence Number: 19973416
• Product Code: FZX
• UDI-Device Identifier: 10887587039152
• UDI-Public: (01)10887587039152
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2021

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 Expiration Date: 01/10/2019
• Device Model Number: 323.204
• Device Catalogue Number: 323.204
• Device Lot Number: 3974934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2021
• Supplement Date Received by Manufacturer: 11/02/2021; 11/02/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/02/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/1999
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown