MAUDE Adverse Event Report: ARTHREX INC. ACUTE AC REPAIR KIT; WASHER, BOLT NUT

Catalog Number AR-2271

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review revealed nothing relevant to the event.If the device is returned and additional information is obtained, a follow-up report will be submitted.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported by patient that on (b)(6) 2016 he had a right ac reconstruction involving an arthrex tightrope and dog bone button, which was performed at one facility.Patient stated his clavicle popped out again and in (b)(6) 2016 he underwent a revision procedure, which was performed by a different surgeon at a different facility.Patient also stated that during the revision the fibertape was found to be ripped and the metal dog bone button was embedded in the bone.No further information was available from patient at time of initial report.Follow-up investigation: patient has provided medical records and part number.Patient states he sustained an infection after surgery and approximately one month post surgery was in a lot of pain and notice bone protruding as it had before surgery.Patient followed up with regular surgeons who recommended waiting to see if the area healed.Pain continued and he sought a second opinion.The second opinion surgeon performed a revision surgery on (b)(6) 2016.Patient states since revision he still has pain in shoulder that radiates down arm and fingers.Patient cannot sleep on his right side.Patient states pain triggers headaches.Patient states his right arm is his dominant arm and pain has affected his work ability and personal abilities.Operative report (b)(6) 2016 - the following device was implanted during the (b)(6) 2016 procedure: ar-2271, acute ac repair kit, lot 1344260.Operative report (b)(6) 2016 - the ar-2271 was explanted during the (b)(6) 2016 revision procedure.When explanting the original device a part of the original implant on the undersurface of the coracoid was ingrown into the undersurface of the coracoid and surgeon left it intact.Surgeon noted that he feared if they tried to remove it, it would weaken that junction and potentially expose the patient to risk of stress fracture or erosion through the bone by the sutures and graft.To complete the revision procedure the surgeon implanted the following devices: ar-2323pslc lot 10017560 and lot 10025443 (qty 1 each).Patient male, (b)(6).Patient (b)(6) at time of revision.

Event Description

It was reported by the patient that on (b)(6) 2016 a right ac reconstruction was performed using an arthrex tightrope and dog bone button.The patient stated that his clavicle popped out again and in (b)(6) 2016 he underwent a revision procedure, which was performed by a different surgeon at a different facility.The patient also stated that during the revision the fibertape was found to be ripped and the metal dog bone button was embedded in the bone.No further information was available from the patient at the time of initial the report.Additional information obtained 3/26/18: the patient provided his medical records including the arthrex part and lot number.The (b)(6) 2016 operating room record identified the device that was implanted as the ar-2271, acute ac repair kit, lot 1344260.The patient stated that he sustained an infection after the (b)(6) 10th surgery and approximately one month post-op he was in a lot of pain and noticed the clavicle bone protruding as it had before surgery.The patient followed up with the implanting surgeon who recommended waiting to see if the clavicle would heal on its own.The patient's pain continued and he sought a second opinion.The second surgeon performed a revision surgery on (b)(6) 2016.Following the revision, the patient reported experiencing pain in his shoulder that radiated down his arm and fingers.He cannot sleep on his right side and the pain also triggers headaches.The patient is right arm dominant and the pain has affected his work and personal life.During the (b)(6) 2016 revision it was found that the part of the dog bone implant on the undersurface of the coracoid was ingrown into the bone so the surgeon opted to leave that piece intact.The surgeon noted that removing it would weaken that junction and potentially expose the patient to a possible stress fracture or erosion through the bone by the sutures and graft.The remainder of the implant was removed from the undersurface of the coracoid and over the clavicle.To complete the revision procedure the surgeon implanted two peek swivelock's: ar-2323pslc lot 10017560 and lot 10025443 (qty 1 each).Patient male, date of birth (b)(6) 1969.Patient age was 47 at time of revision.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This follow-up is for a correction to the event description.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The device history record review revealed nothing relevant to the event.If the device is returned and additional information is obtained, a follow-up report will be submitted.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

• Brand Name: ACUTE AC REPAIR KIT
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7447388
• MDR Text Key: 106072509
• Report Number: 1220246-2018-00146
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867026605
• UDI-Public: 00888867026605
• Combination Product (y/n): N
• PMA/PMN Number: K052776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: AR-2271
• Device Lot Number: 1344260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 03/26/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR