MAUDE Adverse Event Report: DEPUY MITEK ARTHRO KNOT MANIP FULL *EA; INSTRUMENT, LIGATURE PASSING AND KNOT TYING

Catalog Number	214615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Udi: incomplete (b)(4).The expiration date and lot/serial number are currently unavailable.As of this date, the device has not been returned for evaluation.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate via e-mail that during a rotator cuff repair, when typing down sutures using the knot pusher, it was observed that the suture broke half way up the suture.It was reported that the surgeon noticed a sharp scratch/groove on the internal tip of the knot pusher.An alternate knot pusher was used for remainder of the case.There was no delay to procedure and no adverse effect on the patient reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Udi (b)(4).
Event or Problem Description
It was reported by the affiliate via e-mail that during a rotator cuff repair, typing down sutures using the knot pusher & suture broke 1/2 way up the suture.Surgeon noticed a sharp scratch / groove on the internal tip of the knot pusher.An alternate knot pusher was used for remainder of the case.There was no delay to procedure and no adverse effect on the patient reported.Additional event information received on 10/18/2018.Engineers assessment will be uploaded upon receipt.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Udi:(b)(4).
Event or Problem Description
Additional event information received on 10/23/2018.Engineers assessment.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by dfa.Depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch.A follow-up medwatch will be filed as appropriate.Udi:(b)(4).The lot number is not currently available.
Event or Problem Description
Additional event information received on 11/21/2018.It was reported by an affiliate that the entire suture was removed from the patient.Orthocord suture was used to complete the procedure.Sliding knot was being tied on the suture when it was broken.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Udi: (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Correction: upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Common Device Name: INSTRUMENT, LIGATURE PASSING AND KNOT TYING
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7951144
• Report Number: 1221934-2018-54899
• Device Sequence Number: 13729318
• Product Code: HCF
• UDI-Device Identifier: 10886705003983
• UDI-Public: 10886705003983
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: E188228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/15/2018

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 Catalogue Number: 214615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 10/23/2018; 11/15/2018; 11/21/2018; 11/15/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 10/23/2018; 10/29/2018; 11/19/2018; 11/23/2018; 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1