MAUDE Adverse Event Report: DEPUY SPINE INC QUICK CONNECT SI POLYDRIVER; SCREWDRIVER

Catalog Number	698340694
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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
On wednesday, (b)(6) during surgery, the (b)(6) hospital scrub nurse tried to load an expedium pedicle screw onto a custom expedium 5.5mm short si polyaxial screwdriver (ds698340694) and noticed that it was difficult to load the screw.Upon further investigation, she noticed that the bottom thread of the screwdriver was missing and that it had potentially sheered off.It is our belief that this did not happen during the surgery as the screwdriver had not been used yet, but rather at some point prior to the case and went unnoticed.The screwdriver was set aside and a second, identical screwdriver was used appropriately for the remainder of the case.This did not cause a significant delay to the surgery (maybe 2 min).This also did not cause any undue harm to the patient (no adverse events occurred).The screwdriver in question has been washed and will be returned to depuy synthes for further investigation.A replacement screwdriver will also need to be issued to the hospital.Patient consequence? : no.Patient consequence description:no consequence to the patient occurred due to this incident.Action taken for procedure:a second identical screwdriver was used appropriately during surgery as a result of this incident.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
Additional Manufacturer Narrative
(b)(4).Visual examination found that the initial threads of the polydriver sleeve were torn.Noted damage suggests that inadvertently cross threading of the polydriver sleeve occurred upon insertion into the tulip head.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn thread on the quick connect si polydriver cannot be determined.Noted damage suggests that inadvertently cross threading of the polydriver sleeve occurred upon insertion into the tulip head.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 and no systemic trends were found, 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: QUICK CONNECT SI POLYDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8020920
• Report Number: 1526439-2018-51028
• Device Sequence Number: 1195008
• Product Code: HXX
• UDI-Device Identifier: 10705034466743
• UDI-Public: (01)10705034466743
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 698340694
• Device Lot Number: GM4307301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other