MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRVD AHR XL 1 #2 UB STR BL-CB; SAW, POWERED, AND ACCESSORIES

Catalog Number 72205061

Device Problem Break (1069)

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

Event Date 09/19/2018

Event Type  malfunction  

Event Description

It was reported that when the drill guide bone was placed, the surgeon attempt to insert the drill down the guide and noticed resistance,the surgeon removed the guide to inspect and notice that the style tip of the suture fix curved anchor inserter had broken off inside the drill guide.Backup was available to completed the procedure.No patient injuries were reported.

Manufacturer Narrative

One suturefix curved crown guide xl length was returned for evaluation.Visual assessment of the device confirmed it is bent.The distal shaft of a curved suturefix anchor inserter has broken off inside the drill guide.The condition of the device indicates excessive force was placed on the guide during use resulting in the observed damage and breakage of the suturefix inserter.Per the device instructions for use ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure".

Event Description

It was reported that when the drill guide bone was placed, while inserting the drill down the guide, it was noticed resistance, it was noticed that the style tip of the suture fix curved anchor had broken off inside the drill guide.Backup was available to completed the procedure.No patient injuries were reported.Attempts were made to retrieve further information but no response was received from the complainant.

Manufacturer Narrative

A (b)(4) device reported on.The complaint indicated that the drill met with resistance inside the guide.Upon removal and inspection it was noticed that the tip of inserter had broken off inside the drill guide." the product was not returned for evaluation.Due to product unavailability, the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences unrelated to manufacture that could compromise product performance or integrity include: 1) incompatible force or torque or leverage applied.2) change of approach during use.3) device bent past intended flex conditions.4) recommended maintenance not performed.

• Brand Name: SUTUREFIX CRVD AHR XL 1 #2 UB STR BL-CB
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7924145
• MDR Text Key: 122327785
• Report Number: 1219602-2018-01354
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72205061
• Device Lot Number: 50710623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1