MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Model Number	319.04
Medical Device Problem Codes	Material Deformation (2976); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
It was reported on (b)(6) 2021 during a wrist fusion procedure, while using a depth gauge, the surgeon complained that the depth gauge was not performing well and sticking.The tip also seemed to be bent.There was no surgical delay.The surgery was able to be successfully completed.No patient consequences.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for complaint (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.H10 additional narrative: d4 - lot# and expiration date.G4 - manufacture address.H4 - device manufacture date.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
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.H3, h6: a product investigation was conducted.Service & repair evaluation: the repair technician reported the tip of gauge is bent and the etch of the outer sleeve doesn't match the inner shaft.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Visual inspection: the depth gauge for 2.7 mm and small screws (p/n: 319.04, lot #: a4hg998) was returned and received at us cq.Upon visual inspection the tip of the depth gauge was observed to be bent.The reported condition of jammed cannot be confirmed.No other visual defects were observed with the device.Dimensional inspection: a dimensional inspection could not be performed due to post manufacturing defect.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Since the exact manufactured date of the sider assembly 319.01 was not identified, the current revision of drawings was reviewed.Yes, the tip of the device received was bent.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the depth gauge for 2.7 mm and small screws (p/n: 319.04, lot #: a4hg998).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to the device incorrectly reassembled during the sterilization process.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.H3, h4, h6: a device history record (dhr) review was conducted: part # 319.04.Synthes lot # a4hg998.Supplier lot # na.Release to warehouse date: 07 apr 1998.Manufactured by synthes brandywine.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11921743
• Report Number: 2939274-2021-02730
• Device Sequence Number: 19650650
• Product Code: HTJ
• UDI-Device Identifier: 10886982189974
• UDI-Public: (01)10886982189974
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/05/2021

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: 319.04
• Device Catalogue Number: 319.04
• Device Lot Number: A4HG998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 06/30/2021; 07/02/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 06/28/2021; 06/30/2021; 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 103