MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 22MM; SCREW, FIXATION, BONE

Catalog Number VS303.022

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Pma/510k#: device is a veterinary product.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

Veterinary complaint: it was reported that during a surgery on (b)(6) 2020, the surgeon came across a defective screw.The threads were messed up to the point that surgeon could not get the screw into the bone.There was no surgical delay reported.The procedure was completed by using another screw of the same size.There was no impact to the patient.Concomitant devices reported: 3.5mm tplo plate (part# unknown, lot# unknown, quantity# 1); 3.5mm locking screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 3.5mm locking screw slf-tpng w/stardrive recess 22mm.This is report 1 of 1 for complaint (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.H6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed since a screw was observed worn in the images provided.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.H3, h4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 14-feb-2020, part number: vs303.022, 3.5mm locking screw slf-tpng w/stardrive recess 22mm, lot number: 42p7250 (non-sterile), lot quantity: 171.Production order traveler met all inspection acceptance criteria.Inspection sheet, mill threads / thread head / flute / final inspection, met all inspection acceptance criteria.Packaging label log (pll) lppf rev c, lmd rev a was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all visual, dimensional and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 212.107.999, 3.6mm screw blank 22mm 0 3.5 locking screw w/sd15, lot number: 27p4968, lot quantity: 891.Production order traveler met all inspection acceptance criteria.Inspection sheet, heading, 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 manufacture 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.

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.Investigation summary: investigation flow: damage.Visual inspection: the 3.5mm locking screw slf-tpng w/stardrive recess 22mm (part #: vs303.022 and lot #: 42p7250) was received at us cq.Upon visual inspection, the screw was found to be stripped at its proximal end.No further visual defects or deficiencies were noted.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection could be performed due to post-manufacturing damage.Document/specification review: all current and manufactured drawings were reviewed: complaint confirmed? yes.Investigation conclusion: the complaint is confirmed as the screw was stripped.There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 lot : manufacturing location: monument.Manufacturing date: feb 14, 2020.Part number: vs303.022, 3.5mm locking screw slf-tpng w/stardrive recess 22mm.Lot number: 42p7250 (non-sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, mill threads / thread head / flute / final inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all visual, dimensional and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 212.107.999, 3.6mm screw blank 22mm 0 3.5 locking screw w/sd15.Lot number: 27p4968.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, heading met all inspection acceptance criteria.Manufacturing location: monument.Manufacturing date: feb 14, 2020.Part number: vs303.022, 3.5mm locking screw slf-tpng w/stardrive recess 22mm.Lot number: 42p7250 (non-sterile).Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, mill threads / thread head / flute / final inspection met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all visual, dimensional and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 212.107.999, 3.6mm screw blank 22mm 0 3.5 locking screw w/sd15.Lot number: 27p4968.Lot quantity: (b)(4).Production order traveler met all inspection acceptance criteria.Inspection sheet, heading, ns040979 rev t met all inspection acceptance criteria.Device history review: jul 08, 2020: dhr reviewed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.,null.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: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 22MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10320374
• MDR Text Key: 200267791
• Report Number: 2939274-2020-03295
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982015563
• UDI-Public: (01)10886982015563
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS303.022
• Device Lot Number: 42P7250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 10/14/2020
• Patient Sequence Number: 1
• Treatment: UNK - 3.5MM LOCKING SCREWDRIVERS; UNK - 3.5MM TPLO PLATES; UNK - 3.5MM LOCKING SCREWDRIVERS; UNK - 3.5MM TPLO PLATES