MAUDE Adverse Event Report: CONMED LARGO SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	C6360
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the device c6360, spectrum ii suture hook, 45 degree right, was being used on (b)(6) 2023 during a shoulder instability procedure when it was reported ¿spectrum hook right 45 degree broke when passing the tissue.Try to take it out, but the piece broke when to antero inferior axillary pouch.So couldn¿t take it out.¿.The procedure was completed without the use of an alternate device and a 1-hour delay was reported.There was no report of medical intervention, or hospitalization required for the patient.This report is being raised on the reported injury due to patient retaining a foreign object.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised that if the hook or needle bends during use, immediately discontinue use and discard.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.Avoid lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.Void lateral stresses to the instruments or device function may be compromised.There is an increased risk of hook or needle breakage, and unintentional patient injury may result.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device c6360, spectrum ii suture hook, 45 degree right, was being used on (b)(6) 2023 during a shoulder instability procedure when it was reported ¿spectrum hook right 45 degree broke when passing the tissue.Try to take it out, but the piece broke when to antero inferior axillary pouch.So couldn¿t take it out.¿.The procedure was completed without the use of an alternate device and a 1-hour delay was reported.There was no report of medical intervention, or hospitalization required for the patient.This report is being raised on the reported injury due to patient retaining a foreign object.

• Brand Name: SPECTRUM II SUTURE HOOK, 45 DEGREE RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16960349
• Report Number: 1017294-2023-00047
• Device Sequence Number: 14761982
• Product Code: LXH
• UDI-Device Identifier: 10845854018385
• UDI-Public: (01)10845854018385(11)220218(10)1227793
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C6360
• Device Catalogue Number: C6360
• Device Lot Number: 1227793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic