MAUDE Adverse Event Report: DEPUY SPINE INC MOD SQUARE EXP 5.5 SI DRIVER; SCREWDRIVERES

Model Number	698341353
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device deemed reportable at the conclusion of the investigation on march 11, 2019.Reporter is company representative.The mod square exp 5.5 si driver (part # 698341353/ lot # gm54969mt) was received at us cq.The device was received assembled, the distal tip of the device was clearly broken.None of the drive feature remained.No fragments were returned.The overall complaint was confirmed due to the identified broken condition.Device failure/defect identified? yes; distal tip of the device was broken.Dimensional inspection: dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was confirmed for the received mod square exp 5.5 si driver.Although no definitive root-cause can be determined, its possible the device experienced unintended forces while in use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: a review of the receiving inspection (ri) for the mod square exp 5.5 si driver was conducted identifying that lot number gm54969mt was released in two batches.Batch1: lot qty of 4 units was manufactured on 3-sep-2019.Nr-0131782 was initiated due to material not meeting required condition -dwg-103043189, note 1: heat threat per mps-sop-m/008 rev:12.It was found that the supplier had made a documentation error and had released the product with the wrong paper certificate which is why this was identified as a non-conformance.The supplier sent the appropriate paper-work, this non-conformance was resolved and did not contribute to the complaint condition batch2: lot qty of 4 units were released on 2-oct-2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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
It was reported that on an unknown date, the custom made expedium powerease driver tip stripped out during screw insertion.Procedure was successfully completed without surgical delay.There was no patient consequences.This is report 1 of 1 for (b)(4).

• Brand Name: MOD SQUARE EXP 5.5 SI DRIVER
• Common Device Name: SCREWDRIVERES
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9888204
• Report Number: 1526439-2020-00791
• Device Sequence Number: 11212625
• Product Code: HXX
• UDI-Device Identifier: 10705034473703
• UDI-Public: (01)10705034473703
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 698341353
• Device Catalogue Number: 698341353
• Device Lot Number: GM54969MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/27/2020
• Patient Sequence Number: 1