MAUDE Adverse Event Report: DEPUY MITEK LLC US TIBIAL GUIDE BULLET; BONENAIL GUIDEWIRE

Catalog Number	219390
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure it was found that the prongs at the tip of their tibial guide bullet are bent.The procedure was completed with another like device with no patient harm or surgical delay to the case.The sales rep could not provide a lot number for device but stated that the device is older device.The device will be returning for evaluation.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.Investigation summary: the complaint device was received and evaluated.Visual observation confirms the distal end is bent, consistent with excess force being applied at an angle.This failure could be attributed to user error.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.However, 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.Udi:(b)(6).The lot number is unknown.
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.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: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TIBIAL GUIDE BULLET
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9539990
• Report Number: 1221934-2020-00014
• Device Sequence Number: 14024116
• Product Code: FZK
• UDI-Device Identifier: 10886705006199
• UDI-Public: 10886705006199
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 219390
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 01/13/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 01/09/2020; 01/14/2020
• Patient Sequence Number: 1