MAUDE Adverse Event Report: DEPUY MITEK IDEAL SUTGRASPER 30 DEG *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	251721
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the suture device was being used with a second suture grasper device.The mfr number for the 2nd report is mfr:1221934-2018-54875.Device manufacture date is unknown.The device lot number is unknown.(b)(4)-incomplete as the lot number was not available.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported via email from a sales representative, who received a doctor¿s forum email thread reporting issues with ideal 30 degree and 60 degree suture passers.Eight doctors were on the email thread.The reported problem was that the suture passer was stripping when pulling out sutures in the sliding, not grasping, position.This complaint is being opened to document a complaint event reported from one of the eight doctors.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded and not available for evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.We cannot discern a root cause for the reported failure mode, a non-conformance has been opened to further investigate this issue and determine the root cause for the failure.At this point in time, no corrective action is required, and no further action is warranted.However, should any new information be provided in future, this file will be re-opened, and a thorough investigation will be performed.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)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.

• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7951192
• Report Number: 1221934-2018-54873
• Device Sequence Number: 1531070
• Product Code: NBH
• UDI-Device Identifier: 10886705012299
• UDI-Public: 10886705012299
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: E370777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 251721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1