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

Model Number 319.01

Device Problems Crack (1135); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.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

Device report from (b)(6) reports an event as follows: it was reported on an unknown date that the depth gauge had a bent and cracked metal probe.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (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.Additional narrative: 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.H3, h6: part number:319.01, synthes lot number: 5322029, supplier lot number: n/a, release to warehouse date: 20oct2006, expiration date: n/a, manufactured by synthes brandywine.Mrr was generated during production for marks and scratches on hooks.Parts were re-worked and released.This non-conformance is not relevant to the complaint condition since it is not related to bent and cracked metal probe.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the depth gauge for screws dia 2.7 to 4.0 mm, measuring range up to 60 mm (p/n: 319.01, lot #: 5322029) was returned and received at us customer quality (cq).Upon visual inspection, the distal tip of the probe component was bent.The knurled cap and the nipple were missing from the device.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, there was conclusive evidence that the returned device was missing components.Service and repair evaluation: the customer reported the device was bent and cracked.The repair technician reported the knurled cap and nipple components were missing and the tip of the probe was bent and cracked.Tip broken 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.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed depth gauge for 2.7 mm to 4.0 mm screws.Complaint confirmed? yes, the device received was bent.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the depth gauge for screws dia 2.7 to 4.0 mm, measuring range up to 60 mm (p/n: 319.01, lot #: 5322029).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 unintended forces applied to the device.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 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
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10643774
• MDR Text Key: 210410763
• Report Number: 2939274-2020-04561
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: 10886982189950
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.01
• Device Catalogue Number: 319.01
• Device Lot Number: 5322029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1