MAUDE Adverse Event Report: DEPUY SPINE INC KERRISON ROD HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	277030110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2019, after anterior & posterior lumbar fusion surgery, the kerrison rod holder broke.It was unknown how the issure was discovered.There were no patient consequences.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (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.Upon visual inspection, it was observed that one of the lever spring was completely broken near the spring screw and the broken fragments were not returned.Rest of the device shows some scratches caused due to regular use which has no impact on the functionality of the device.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: KERRISON ROD HOLDER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8804249
• Report Number: 1526439-2019-51846
• Device Sequence Number: 457644
• Product Code: LXH
• UDI-Device Identifier: 10705034196619
• UDI-Public: (01)10705034196619
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2019

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 Model Number: 277030110
• Device Catalogue Number: 277030110
• Device Lot Number: 0605K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 09/13/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/07/2019; 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1