MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRSEW III AC+ RTN PLATE 5PK; SUTURE/NEEDLE PASSER, SINGLE-USE

Model Number 288234

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: udi: (b)(4).The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.Investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, 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: no lot numbers were supplied which precludes conducting a dhr review or a lot-specific search in the complaints handling system.

Event Description

It was reported by the affiliate in (b)(6) that during a shoulder repair procedure on an unknown date, it was observed that the retention plate on the exprsew iii ac+ rtn plate device was not removed after the end of the surgery.According to the report, a second plate was put on top for a new surgery as the plate fell inside the patient.It was reported that although fragments were generated and were not removed, the procedure was completed successfully.It was reported that an x-ray was performed after the surgery on the patient.It was reported that the patient was scheduled to have a second surgery to remove the plate.The status of the patient post-surgery was unknown.No additional information was provided.

• Brand Name: EXPRSEW III AC+ RTN PLATE 5PK
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13660235
• MDR Text Key: 287598137
• Report Number: 1221934-2022-00699
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027118
• UDI-Public: 10886705027118
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 288234
• Device Catalogue Number: 288234
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention