MAUDE Adverse Event Report: CANNULATED CONNECTING SCREW; ROD,FIXATION,INTRAMEDULLARY

Model Number 03.037.010

Device Problem Device-Device Incompatibility (2919)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, the helical blade inserter had a piece broke off of the inserter.It was removed and put it back, but it is not staying well.We were able to put it back on and make it work, but it is not staying well.Also, the cannulated connecting screw threads are rough causing the removal of the insertion handle difficult.There were 10 minutes surgical delay.The procedure successfully completed.No patient consequence.Concomitant device reported: unk - insertion instruments (part# unknown; lot# unknown; quantity: 1).This complaint involves three (3) devices.This report is for (1) cannulated connecting screw.This report is 3 of 3 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.H3, h6: the subject device has been 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.

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, h6: a product investigation was conducted.Visual inspection: the cannulated connecting screw (part# 03.037.010, lot# 9919785 qty# 1) was returned and received at us cq.Upon visual inspection, no issues were observed with the device.Functional test: functional testing of the received test was not performed at cq as the device was received by itself and the mating devices were not returned.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to the design of the device.Document/specification review: the relevant drawing(s) was reviewed: no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint condition cannot be confirmed for the cannulated connecting screw (part# 03.037.010, lot# 9919785 qty# 1).A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 # 03.037.010.Lot # 9919785.Release to warehouse date: 15 jul 2016.Manufacturer: hagendorf.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.

• Brand Name: CANNULATED CONNECTING SCREW
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• MDR Report Key: 12537286
• MDR Text Key: 273579470
• Report Number: 2939274-2021-05776
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982070265
• UDI-Public: (01)10886982070265
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.037.010
• Device Catalogue Number: 03.037.010
• Device Lot Number: 9919785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CANNULATED CONNECTING SCREW; HELICAL BLADE INSERTER; UNK - INSERTION INSTRUMENT
• Patient Age: 91 YR