MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION ONALENE; ONALENE, -2.0-100 9/0 PP

Model Number	OE172081
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The needle broke off from the suture, in the patient and the surgeon had to spend some time locating it.No other details could be obtained.
Additional Manufacturer Narrative
A review of the device history record was performed.The devices were manufactured in accordance with product specifications.Sterile samples from the same finished good lot were returned for evaluation by the distributor.The devices met the visual requirements and the usp needle pull requirements.No trends were identified.Complaints will continue to be monitored.Previous research has shown that needles detaching or popping off the suture most likely result from the interaction of specific procedural related stress in contrast to the strength of the suture/needle attachment.It is also possible that the devices are being gripped on or near the attachment causing damage to the end of the needle component or snipping the suture which causes the suture to break/snap away from the needle.However, there are numerous other circumstances that can adversely affect the strength and durability of a suture/needle attachment including but not limited to the misalignment of the suture within the end of the needle, the suture material not placed deep enough within the end of the needle and/or if end is not crimped with enough force to form a secure grip onto the suture material.The ¿precautions¿ section in the ifu for these devices¿ states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point.¿ design verification was performed to ensure that the appropriate materials were selected in order to have an appropriate attachment.Appropriate materials were selected to meet the design requirements.Stability studies also confirm that the product meets the design requirement for the indicated shelf life.No further control measures are deemed necessary at this time.

• Brand Name: ONALENE
• Common Device Name: ONALENE, -2.0-100 9/0 PP
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido franciso villa; tijuana baja california 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood MA 02090
• Manufacturer Contact: kelly knappenberger ; corredor tijuana-rosarito 2000; #24702b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 19139480
• Report Number: 3010692967-2024-00029
• Device Sequence Number: 8434382
• Product Code: GAW
• UDI-Device Identifier: 00848782040346
• UDI-Public: (01)00848782040346(17)280120(10)D131ZDN
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2024
• Report Date (Section F): 02/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: OE172081
• Device Lot Number: D131ZDN
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Required Intervention; Other
• Patient Sex: Unknown