MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE

Model Number 313.99

Device Problem Break (1069)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

It was reported that on (b)(6) 2019, the patient underwent removal of five (5) unknown screws and an unknown plate of the fifth metacarpal due to pain.However, the tip of a cruciform screwdriver with holding sleeve broke when trying to remove an unknown last screw.The broken pieces of the screwdriver were removed with ease.Moreover, the surgeon had difficulty removing the last screw because the plate and the screw were welded together, and the screw would not budge.Consequently, the part of the plate and a screw were left in the patient's body.Resulting, the procedure was not completed successfully with a surgical delay of 20 minutes due to an additional tray needed and cutting of the plate.Patient outcome was unknown.Concomitant device reported: unknown screws (part #, lot # unknown, quantity# 4).This is report 1 for 3 (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: visual inspection: the cruciform screwdriver with holding sleeve was received at us customer quality (cq) with the distal tip of the shaft broken obliquely.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed due to the oblique breakage of the distal tip.Document/specification review: the following drawing(s) was reviewed: cruciform screwdriver w/point sm cru scrdr 1.5 & 2.0 a manufacturing record review could not be performed as the lot number is unknown.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.H11 corrected data: d10 h6 - patient codes: the codes for pain (1994) and foreign body (2687) were inadvertently used on the initial medwatch.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: CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9117067
• MDR Text Key: 160040474
• Report Number: 2939274-2019-60863
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188328
• UDI-Public: (01)10886982188328
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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
• Device Operator: Health Professional
• Device Model Number: 313.99
• Device Catalogue Number: 313.99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Age: 56 YR