MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO CLEVERHOOK-RIGHT *EA; SKIN/TISSUE HOOK

Catalog Number	214640
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Initial reporter phone number: (b)(6).Investigation summary :the complaint device was received and inspected.The complaint cannot be confirmed.A visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition, however none were observed.To test the functionality of the device, the jaw was actuated via the trigger several times.No functional anomalies were observed from this operation.A suture was grasped with the device successfully to further test the functionality.Since we could not reproduce the issue experienced by the customer, no root cause is available for the reported failure.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.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate that during an unknown procedure they noticed that the cleverhook handle was getting stuck.The procedure was completed with a second device with no delay to the case.The affiliate did not report any patient harm.
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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Common Device Name: SKIN/TISSUE HOOK
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8492056
• Report Number: 1221934-2019-56780
• Device Sequence Number: 16472615
• Product Code: NBH
• UDI-Device Identifier: 10886705004218
• UDI-Public: 10886705004218
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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): 04/03/2019

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: 214640
• Device Lot Number: 18J02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1