MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 72203290

Device Problems Break (1069); Component Falling (1105); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).The 2.3 curved osteoraptor was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The distal tip of the inserter shaft that interfaces with the anchor has broken off on the device.The broken tip from the device that broke after the case was returned and dimensionally inspected, the tip met print specifications.Shafts were rockwell tested for material condition and were found to meet print specification (rc 40-48) actual was rc 42.4.As reported the guide became isolated from the patients bone surface during insertion.Per the devices ifu under precautions ¿use of excessive force and/or misalignment during insertion can cause failure of the suture anchor and/or flexible insertion device¿.A review of the device history record was performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.Two possible part and lot numbers were provided for this reported incident.The facility could not identify which was the complained device that broke during the procedure.The devices indicated are: part number 72203290 lot 50520778 with a manufacture date of september 29, 2014 and expiration date of september 29, 2019, part number 72203291 lot 50501150 with a manufacture date of april 17, 2014 and march 30, 2019.No further investigation is warranted at this time.(b)(4).

Event Description

During a shoulder labrum repair, it was reported that the tip of the inserter broke.The site was prepped with a flexible drill.According to the surgeon, the curved drill guide got isolated from the bone surface during the insertion.The broken tip fell into the armpit.The surgeon decided to leave it inside the body because it was difficult to remove it.Two anchors broke in this operation; for one of the anchors, not only the anchor but also the inserter broke during insertion; the other anchor broke during insertion.Another broke during cleaning after the operation.The facility has not clarified which device is involved in each breakage.The operation was completed with these two anchors.Both broken anchors remained inside the body.The operation was completed with another brand new anchor.The patient's post-operative condition is good.

• Brand Name: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5079472
• MDR Text Key: 25876545
• Report Number: 1219602-2015-01008
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2019
• Device Catalogue Number: 72203290
• Device Lot Number: 50520778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention