MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSSEW III AC DIVBRD/LOADR; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number	214158
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
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 is not being returned, it was discarded by the customer therefore is unavailable for a physical evaluation.A review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed one other dissimilar complaint for this lot of (b)(4) devices with this product code that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
The sales rep reported via phone that his expressew iii ac loader/plate was to thin and not strong enough to hold the sutures.The suture was not being held by the jaw during a rotator cuff repair.There were no patient consequences or delays.The case was completed with the device.The device was discarded by the customer.The sales rep was not present during the case and could not provide any more details.

• Brand Name: EXPRESSSEW III AC DIVBRD/LOADR
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8352357
• Report Number: 1221934-2019-56439
• Device Sequence Number: 1682801
• Product Code: LXH
• UDI-Device Identifier: 10886705025206
• UDI-Public: 10886705025206
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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 Expiration Date: 09/30/2019
• Device Catalogue Number: 214158
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 02/19/2019
• Patient Sequence Number: 1