MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE; STAPLE, FIXATION, BONE

Model Number LARGE

Device Problem Break (1069)

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

Event Date 07/30/2021

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

It was reported that during a procedure on (b)(6) 2021 the guide broke when inserting the hammertoe cci large.There was a five (5) minutes surgical delay.The procedure was successfully completed by switching to small hammertoe cci.No other medical intervention required.This report is for one (1) depuy synthes hammertoe cci large kit w/1.60 k-wire/ sterile.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: part # 46.239.002.Synthes lot # mhc200011.Supplier lot # mhc200011.Release to warehouse date: 19may2020.Expiration date: 26 mar2025.Supplier: (b)(4).No ncrs 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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: DEPUY SYNTHES HAMMERTOE CCI LARGE KIT W/1.60 K-WIRE/ STERILE
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12380557
• MDR Text Key: 268693575
• Report Number: 2939274-2021-04987
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633022054
• UDI-Public: (01)00810633022054
• Combination Product (y/n): N
• PMA/PMN Number: K191463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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
• Device Operator: Health Professional
• Device Model Number: LARGE
• Device Catalogue Number: 46.239.002
• Device Lot Number: MHC200011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/27/2021
• Patient Sequence Number: 1