MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202595

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

The sample is under evaluation by the manufacturing site.

Event Description

It was reported that during a rotator cuff repair surgery, the metal inserter was found rust, the device was not used in the patient.No delay and a back up device was available to complete the procedure.No patient injury was reported.Preliminary results of investigation have concluded that the unit had bio-matter adhered to the inserter, indicating usage of a rusted device in the patient, which makes it a reportable event.

Manufacturer Narrative

H2, h3, h6.Three 72202595 twinfix ultra pk 4.5mm suture anchors used for treatment were reported on.(see 270784, 271460, 271461) the inserters were returned for evaluation.Three separate complaints were opened.There was discoloration and possible damage and corrosion of the device markings at the distal tips.Initial evaluation was unconfirmed.Complaint history review indicated similar allegations for the lot number reported.Batch review did not indicate a condition or product, procedure failure that supported the allegation, but observations were made from use of a temporary alternate cleaning method when the usual method was being relocated.Further investigation was assigned to engineering.Per engineering: one of the three returned devices shows bio-matter adhered to the inserter distal tip as well as inside the returned packaging.The device appears to have reddish/brown discoloration isolated only to the laser marking.The discoloration is evident on the laser mark for the one device that also contains bio matter but is more prevalent on the laser marking on the proximal end of the tip.Two other devices only show evidence of discoloration on the laser marking at the tip of the inserter.The discoloration appears to be corrosion but this was not confirmed.A review of information shows that the shaft component built into the upper level assembly consisted of four lots with december manufacture dates.A review of non-conformances and deviations was conducted for this time-period with no discrepancies to report.Additionally, there were no changes to the process during this time-period.These parts are laser marked at majestic medical.They were contacted to review preventative maintenance logs, any changes to equipment or anything else that could have been out of the ordinary with no findings to report.The source of the discoloration could not be identified.The failure mode analysis has been updated to account for this failure mode and is routing for approvals.Failure mode will continue to be monitored through surveillance trending.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) although this complaint reported three twinfix ultra pk 4.5mm w/2 ub -wht &bl captured under ((b)(4)) and two previously closed master ((b)(4)), and ((b)(4)) not used in the rotator cuff procedure, the product evaluation revealed bio matter attached to the tips of the inserters indicating usage of a rusted device in the patient.In addition to, a discoloration and possible damage and corrosion of the device markings at the distal tips.Per report, a review of the non-conformance and deviations concluded there were no discrepancies for this time.Additionally, there were no changes to the process during this time.These parts were laser marked majestic medical.Per communications, after a review of the logs by majestic medical there were no abnormal findings.There was no delay and a backup device was available to complete the procedure.No patient injury reported.Conclusion: based on the product evaluation, the root cause of the corrosion could not be determined.Per communications, it was not used on the patient but noting that the product evaluation noted that there was biomatter on the anchor there was no injury reported related to the present patient.Since the biocompatibility of the corrosive material is unknown, the potential of localized pain/discomfort, corrosion, micro-motion and/or migration of the retained corrosion could not be ruled out.Should any additional medical information be provided this complaint will be re-assessed.Approved by (b)(6) md on (b)(6) 2020.Conclusion: based on the product evaluation, the root cause of the corrosion could not be determined.Per communications, it was not used on the patient but noting that the product evaluation noted that there was biomatter on the anchor there was no injury reported related to the present patient.Since the bio-compatibility of the corrosive material is unknown, the potential of localized pain/discomfort, corrosion, micro-motion and/or migration of the retained corrosion could not be ruled out.Should any additional medical information be provided this complaint will be re-assessed.Approved by (b)(6) md on (b)(6) 2020.

• Brand Name: TWINFIX ULTRA PK 4.5MM W/2 UB -WHT &BL
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9833490
• MDR Text Key: 183517553
• Report Number: 1219602-2020-00526
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010647467
• UDI-Public: 03596010647467
• Combination Product (y/n): N
• PMA/PMN Number: K093228
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2024
• Device Model Number: 72202595
• Device Catalogue Number: 72202595
• Device Lot Number: 2027389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1