MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 7X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231800
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189); No Code Available (3191)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It reported by affiliate via email a patient with massive rupture of the rotator cuff, the surgical planning chosen was to perform a tenodesis of the biceps tendon, we used our equipment for this procedure.The kischner pin of the appropriate length was not available to perform the step of passing the screw and fixing the tendon, when trying to find a pin of less length than required (1.6 x 280) it was insufficient to retain the pin in the hole of the humeral head and remove the socket or retainer, with which it was not possible to do this step, after two unsuccessful attempts the tendon breaks causing a retraction of the stump and making it impossible to fix the tendon and affect the rehabilitation of the patient.It was also reported a 30 minute delay occurred.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.B5: subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during biceps tenodesis surgery.The surgery was delayed for 30 minutes due to the event.The procedure was not completed successfully.There were no fragments generated.It was reported that the tendon broke resulting in a proximal and a distal stump.It was reported that the patient had a poor prognosis in his recovery and pain relief.It was reported that there was medical intervention required due to the event.It was reported that there was conversion to open surgery through a small incision to look for the retracted stump.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information provided, it was reported that patient with massive rupture of the rotator cuff, the surgical planning chosen was to perform a tenodesis of the biceps tendon, we used our equipment for this procedure.The kischner pin of the appropriate length was not available to perform the step of passing the screw and fixing the tendon, when trying to find a pin of less length than required (1.6 x 280) it was insufficient to retain the pin in the hole of the humeral head and remove the socket or retainer, with which it was not possible to do this step, after two unsuccessful attempts the tendon breaks causing a retraction of the stump and making it impossible to fix the tendon and affect the rehabilitation of the patient.The complaint device was received and evaluated.Visual observations confirm that the anchor was received intact, it did not present any physical damage.In addition, the anchor didn¿t present any evidence of debris.In other hand, the anchor was measured using a digital caliper, as result, the lengths were according with the drawing of the device.The complaint cannot be confirmed.As per event description indicates the root cause for this failure can be related with the use of the pin of less length than required causing the break and an improper fix of the tendon.A manufacturing record evaluation was performed for the finished device lot number:l689862, and no non-conformances were identified.At this point in 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.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10410582
• Report Number: 1221934-2020-02100
• Device Sequence Number: 3273635
• Product Code: MAI
• UDI-Device Identifier: 10886705010684
• UDI-Public: 10886705010684
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150209
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 231800
• Device Catalogue Number: 231800
• Device Lot Number: L689862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 08/21/2020; 11/06/2020; 01/06/2021
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/24/2020; 11/09/2020; 01/07/2021
• Patient Sequence Number: 1
• Patient Age: 42 YR