MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72200755

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/21/2020

Event Type  Injury  

Event Description

It was reported that during reconstruction of patellar ligament, the screw broke off during use.The procedure was successfully completed using a s&n back-up device.There was delay between 0-30 min.All the pieces were removed from the patient with tweezers.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.H3, h6: one 72200755 twinfix ti 5.0 suture anchor used in treatment, was returned for evaluation.The device was returned with its inserter, tainted loosed suture and a damaged anchor.The inserter hex was stripped from excess torque applied.The proximal anchor head area was visibly distorted.It was bent from force used.Remaining threads were gouged, with edges missing.It was twisted and chewed up.The condition indicated excess force applied and forceful contact with a device or other instrument.Symptoms are aligned with a difficult attempted use.Successful implantation requires following the recommended site prep recommendations.Instructions for use includes technique driven specific instructions: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Breakage of suture anchor can occur if predrilling is not performed prior to implantation.Excessive force during insertion can cause failure of the suture anchor or insertion device.If more torque is required to insert the anchor, stop and ensure that the anchor size, drill hole size, and depth are correct for the bone conditions encountered.It may be necessary to reduce the anchor size or increase the drill hole size to achieve optimal insertion force.It is the responsibility of the surgeon to determine the patient's bone condition, appropriately prepare the insertion site, and determine the suitability of the implant for the procedure.Using the appropriate smith and nephew drill bit and drill guide (each sold separately), prepare the anchor insertion site.¿ complaint history review indicated no similar allegations for the lot number reported.Batch review for the lot number reported, indicated no condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.No indications from the device show cause that the material was related to the reported failure.Root cause related to the manufacture of the device was not confirmed.Product met specifications upon release to distribution.

• Brand Name: TWINFIX TI 5.0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10407369
• MDR Text Key: 202890649
• Report Number: 1219602-2020-01251
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010577986
• UDI-Public: 03596010577986
• Combination Product (y/n): N
• PMA/PMN Number: K972326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200755
• Device Catalogue Number: 72200755
• Device Lot Number: 2039415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 14 YR
• Patient Weight: 55