MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC&ND; SCREW, FIXATION, BONE

Catalog Number	222308
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that two needle devices were involved in this event and the second device is being reported under mfr: 1221934-2018-54887.(b)(4).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 that during a rotator cuff repair procedure, when the suture passed through the tendon, it was observed that the needle and suture junction broke on two of the needles on each anchor.It was reported that the breakage did not result in a surgical delay greater than thirty minutes or an inability to complete the surgical procedure as intended.The reporter stated that the patient had hard bone.There was a surgical delay of three minutes.The reporter stated that no portion of the device remained in the patient.The reporter stated that the there was a potential that the insertion was off axis.The same bone hole was used to complete the surgical procedure and no debris was left in the patient.It was reported that another device was used to complete the procedure.The patient¿s outcome post surgery was a successful repair.The reporter stated there were no adverse events to the patient.
Additional Manufacturer Narrative
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 additional information should become available, a supplemental medwatch will be submitted accordingly.Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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.
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).

• Brand Name: 5.5 HEALIX ADVANCE PEEK W/OC&ND
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7951087
• Report Number: 1221934-2018-54888
• Device Sequence Number: 16526835
• Product Code: HWC
• UDI-Device Identifier: 10886705021437
• UDI-Public: 10886705021437
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K120449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2018

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 222308
• Device Lot Number: L436539
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 12/13/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/10/2018; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1