MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTGRASPER 30 DEG *EA; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	251721
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
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.Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.A visual inspection revealed no hair or any other similar foreign materials that may be perceived as hair on or inside the device which may be observed by the end user upon receiving the device.Given this observation, we cannot discern a root cause for the issue reported by the customer.A non-conformance search was conducted to investigate any defects identified during production that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.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)-incomplete.The expiration date is unknown.
Event or Problem Description
It was reported by the customer via phone that during a shoulder repair procedure, but prior to use on the patient, the customer's ideal suture grasper 30 degree had a long hair inside the device.The case was completed with another like-device with no patient harm or delay.The customer was not present and could not provide any additional information.The device is being returned for evaluation.

• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8378764
• Report Number: 1221934-2019-56511
• Device Sequence Number: 19564567
• Product Code: NBH
• UDI-Device Identifier: 10886705012299
• UDI-Public: 10886705012299
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: 251721
• Device Lot Number: 1L85499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/28/2019
• Patient Sequence Number: 1