MAUDE Adverse Event Report: SURGICAL SPECIALTIES STRATAFIX SUTURE; 2FS-2 3-0 UNDYD MONODERM 14X14

Model Number	SXMD2B407
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A batch review of the reported lot indicates there were no non-conformances reports issued for the finished goods lot.The product from this finished goods lot and all of the components met surgical specialties requirements throughout the incoming, manufacturing and the final inspection processes.The needle is an ethicon component.No samples were returned for testing or review.There were no retained samples available for testing.Ethicon third party summary has not been received to date.A potential root cause for a needle detaching when tugged during the procedure could be that the suture was not fully inserted within the end of the needle during the manufacturing process.It¿s also possible the device was grasped on the swaged end of the needle causing damage to the suture material allowing the needle to break away from the suture strand.Without receiving and reviewing the actual detached device, reviewing magnified photo(s), of the detached device or receiving detailed information regarding the storage and handling of the material, preoperative preperation of the device(s), tools utilized to grasp the device(s), procedure(s) performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.The ¿precautions¿ section in the ifu for the suture/needles 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.
Event or Problem Description
It was reported that during c-section surgery, the needle pulled off suture when sewing skin tissue.X rays were used to look for the needle but could not find it.The needle was left in the patient.Changed to another one to complete the procedure.The delay in the procedure was approximately 4.5 hours.The patient is reportedly stable in hospital now.

• Brand Name: STRATAFIX SUTURE
• Common Device Name: 2FS-2 3-0 UNDYD MONODERM 14X14
• Manufacturer (Section D): SURGICAL SPECIALTIES; corredor tijuana rosarito 2000; #24702 b, ejido francisco vill; tijuana 22235 ; MX 22235
• MDR Report Key: 10800400
• Report Number: 3010692967-2020-00036
• Device Sequence Number: 11655124
• Product Code: GAM
• UDI-Device Identifier: 10705031208087
• UDI-Public: (01)10705031208087(20)12(17)240930(10)AAFE109
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2020
• Report Date (Section F): 10/26/2020

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 Expiration Date: 09/30/2024
• Device Model Number: SXMD2B407
• Device Lot Number: AAFE109
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2020
• Device Age: 1 YR
• Date Report to Manufacturer: 10/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention