MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 28MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	04.201.028
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).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 during removal surgery on (b)(6) 2019, one (1) titanium (ti) cancellous locking screw and one (1) unknown screw was unable to be removed from being locked (cold weld) into an unknown antegra alif plate.Originally, the patient had hip surgery and was implanted with one plate and four screws.On (b)(6) 2019.On an unknown date after the implant surgery, it was found out that two screws were a little too long and the surgery wanted to shorten the screws.The surgeon cannot remove the screw that was cold-welded to the plate despite numerous efforts.However, only one screw was removed and the other one stayed in place.It is unknown if there was a surgical delay.No harm to the patient.This is 3 of 3 for report (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Event: updated event description and added concomitant devices.Concomitant medical products: added concomitant devices.A device history record (dhr) review was conducted: manufacturing location: supplier ¿ bel-pro products (bpp) / inspected, packaged and released by: monument.Release to warehouse date: 13-feb-2019.Part number: 04.201.028, 6.0mm ti cancellous locking screw w/stardrive recess 28mm lot number: h776223 (non-sterile).Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Component part(s) reviewed: part number: bt25t6.5l044w, blank 6.5mm ti w/t25.Lot number: h772496.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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.(b)(4).
Event or Problem Description
Updated event description: it was reported that during hardware removal surgery on (b)(6) 2019, one (1) titanium (ti) cancellous locking screw 32mm and one (1) titanium (ti) cancellous locking screw 28mm were unable to be removed due to they being locked (cold welded) into the ti antegra alif plate.Originally, the patient had hip surgery on (b)(6) 2019 and was implanted with one plate and four screws.On an unknown date after the initial surgery, it was found out that two screws were a little too long and the surgeon wanted to shorten the screws.The surgeon cannot remove the screw that was cold-welded to the plate despite numerous efforts.However, only one screw was removed and the other one stayed in place.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant devices reported: unknown screws (part# unknown, lot# unknown, quantity# 2) this report is for one (1) 6.0mm ti cancellous locking screw w/stardrive recess 28mm.This is report 3 of 3 for complaint (b)(4).

• Brand Name: 6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 28MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9369499
• Report Number: 2939274-2019-62372
• Device Sequence Number: 14169666
• Product Code: KWQ
• UDI-Device Identifier: 10705034733869
• UDI-Public: (01)10705034733869
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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 Model Number: 04.201.028
• Device Catalogue Number: 04.201.028
• Device Lot Number: H776223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention