MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222245
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: complaint summary: it was reported by sales rep via complaint submission tool that during a shoulder arthroscopy when opening a 5.5 healix ti anchor w/ orthocord, its sutures were cut, inside the original packaging.It was not used in the patient.No surgical delay or patient consequences reported.Investigation summary: during visual inspection: the device was received at cq in original packaging.The original packaging was found to be opened (tapped on).After taking the device out, it was noticed the suture is cut/broken.However complaint of upon receipt: device damaged can not be confirmed since the device was received in open/tapped on package.A manufacturing investigation was done by cyril: a manufacturing investigation activity has been performed to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.There has been a closer look on the assembling and on the in-process controls.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.Based on the information provided we cannot discern a definitive root cause for the reported failure.At this time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
Event or Problem Description
It was reported by sales rep via complaint submission tool that during a shoulder arthroscopy when opening a 5.5 healix ti anchor w/ orthocord, its sutures were cut, inside the original packaging.It was not used in the patient.No surgical delay or patient consequences reported.Additional information provided by the affiliate reported the case was completed with another available anchor.

• Brand Name: 5.5 HEALIX TI ANCHOR W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10935227
• Report Number: 1221934-2020-03680
• Device Sequence Number: 14142680
• Product Code: HWC
• UDI-Device Identifier: 10886705007912
• UDI-Public: 10886705007912
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K082282
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 222245
• Device Catalogue Number: 222245
• Device Lot Number: 6L50337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/02/2020
• Patient Sequence Number: 1