MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL TI RIB HOOK; PROSTHESIS, RIB REPLACEMENT

Model Number	04.641.002
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent a spine procedure.During the procedure, the nut of a rib hook would not lock with the torque limiting wrench and would just keep spinning.The surgeon tightened another rib hook to verify the torque limiting device was not the issue.The surgeon then removed the malfunctioning rib hook and replaced it with a different identical hook.There was a fifteen (15) minutes surgical delay.The procedure was successfully completed with no patient consequence.Concomitant device reported: torque limiting wrench (part/lot unknown, quantity 1); locking caps (part/lot unknown, quantity unknown).This report is for a rib hook.This is report 1 of 1 for (b)(4).
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.H11: d10: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: SMALL TI RIB HOOK
• Common Device Name: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8672115
• Report Number: 2939274-2019-58493
• Device Sequence Number: 381183
• Product Code: MDI
• UDI-Device Identifier: 10705034749839
• UDI-Public: (01)10705034749839
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142587
• 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
• Report Date (Section B): 05/06/2019

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: 04.641.002
• Device Catalogue Number: 04.641.002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1