MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL; PLIERS, SURGICAL

Catalog Number 03.130.270

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 that on an unknown date that the plate cutter broke in process of cutting.There was a delay of two (2) minutes and the surgery was completed successfully.Concomitant device: unknown plates: hand (part# unknown; lot# unknown; quantity: 1).This report is for one (1) plate cutter/in-line for 1.3mm lckng/1.5-2.0mm val pl.This is report 1 of 1 for (b)(4).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4: updated.D9: device returned.Investigation summary: background: plate cutter broke in process of cut.Updated event description: concomitant device reported: unknown plates: hand (part# unknown; lot# unknown; quantity: 1) this complaint involves one (1) device.H6: investigation flow: damage visual inspection: the cutt-pliers in-line f/lock pl 1.3+va loc (p/n: 03.130.270, lot #: t126575) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip of the lower jaw component was broken and the broken fragment was returned.The plate holder was missing from the device.No other issues were observed with the returned device.Device failure/defect was identified.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed inline plate cutter: 03_130_270, rev.C/a.Complaint was confirmed, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the cutt-pliers in-line f/lock pl 1.3+va loc (p/n: 03.130.270, lot #: t126575).There is no indication that a design or manufacturing issue has caused the complaint condition 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.H3, h4, h6: device history lot part number: 03.130.270.Lot number: t126575.Manufacturing site: tuttlingen.Release to warehouse date: 10-jan-2016.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11889673
• MDR Text Key: 252945314
• Report Number: 2939274-2021-02615
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 07611819690721
• UDI-Public: 07611819690721
• 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
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.130.270
• Device Lot Number: T126575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: HAND