MAUDE Adverse Event Report: DEPUY MITEK LLC US 7.0 X 75MM REUSABLE OBTURATOR -NS; SURGICAL DRILL GUIDE OBTURATOR

Catalog Number	214113
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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.Udi:(b)(4).
Event or Problem Description
It was reported by the affiliate via complaint submission tool that during kit inspection the 7.0 x 75mm reusable obturator ns fell out of the handle.No patient consequence and no surgical delay was reported.No additional information was provided.
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.H10 additional narrative: correction: d10: the date device returned to manufacturer was documented as 10/31/2019 on the initial report and has been updated as 10/30/2019.Additional information: investigation summary: the complaint device was received and inspected.Upon visual inspection it was noted that the handle and the metal shaft had separated.Base of the handle had stripped as well.This complaint can be confirmed.It is possible the device has seen heavy use and has been used beyond its design intent eventually leading to this failure.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Device history lot the potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.

• Brand Name: 7.0 X 75MM REUSABLE OBTURATOR -NS
• Common Device Name: SURGICAL DRILL GUIDE OBTURATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9312824
• Report Number: 1221934-2019-59494
• Device Sequence Number: 11295534
• Product Code: LXH
• UDI-Device Identifier: 10886705003549
• UDI-Public: 10886705003549
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 10/15/2019

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 Catalogue Number: 214113
• Device Lot Number: 1204002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1