MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN STR *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214600

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

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 Description

It was reported by the sales rep via phone that this penetrating grasper straight broke during an unknown procedure.Another device was used to complete the procedure.No patient consequence or surgical delay reported.

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.Udi:(b)(4).

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: investigation summary: the complaint device was received and evaluated.A functional and visual inspection was performed to determine if the device had any gross visual defects that may contribute to the reported complaint condition.No anomalies were identified.The device functions as intended.Therefore, the reported failure of the device being broken is not confirmed.Furthermore, we cannot determine a root cause.A manufacturing record evaluation was performed for the device lot number, and no non-conformances were identified.At this point, no corrective action is required, and no further action is warranted.However, depuy synthes 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 a manufacturing record evaluation was performed for the finished device [09g1] number, and no non-conformances were identified.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9364516
• MDR Text Key: 207730583
• Report Number: 1221934-2019-59730
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705003839
• UDI-Public: 10886705003839
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 214600
• Device Lot Number: 09G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/26/2019; 01/02/2020
• Supplement Dates FDA Received: 12/20/2019; 01/03/2020
• Patient Sequence Number: 1