MAUDE Adverse Event Report: DEPUY SPINE INC SKY TFP INSERTER; DRIVER

Model Number	286850000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported that on an unknown date that the temporary fixation pin inserter cannot be disassembled.The instructions for use (ifu) suggests a ph value of 7 - 9 to clean the instrument but the customer needs an approval to clean the instrument with a ph value of greater than (>) 10.There was no patient involvement.This report is for one (1) sky tfp inserter.This is report 1 of 1 for (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.H10 additional narrative: h3, h6: investigation summary background: customer is complaining that the "temporary fixation pin inserter" cannot be disassembled and that the ifu suggests a ph value of 7 - 9 to clean the instrument but the customer needs an approval to clean the instrument with a ph value of greater than (>) 10.Not related to any surgery.No patient involvement.This complaint involves one (1) device.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided in the attachment ¿source picture¿.The image was reviewed, and the complaint condition could not be confirmed since there is no indication in the surgical technique guide or in the design drawing that the device should be able to disassemble.Several of the internal components are noted in the design drawing to be secured using loctite.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: SKY TFP INSERTER
• Common Device Name: DRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10071711
• Report Number: 1526439-2020-01043
• Device Sequence Number: 3751922
• Product Code: HWR
• UDI-Device Identifier: 10705034215464
• UDI-Public: 10705034215464
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 05/06/2020

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: 286850000
• Device Catalogue Number: 286850000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1