MAUDE Adverse Event Report: HUMERAL RULER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71751126
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an inspection in the warehouse it was noticed the failure of defective devices.It was reported that three universal insert spacer size 1-2 18 mm ((b)(4)), the tibial spacer block standard ((b)(6)) the journey ii xr tibial base implant impactor ((b)(4)) and the journey uni tibial trail insert size 3-4/ 9 mm ((b)(4)) were noticed cracked.The screw depth gauge ((b)(4)), meta-tan anti rotation bar ((b)(4)), humeral ruler ((b)(4)), two screw driver release handle ((b)(4)), the journey dcf ap fem cut blk 4 ((b)(4)) the journey ii tka femoral trial left size 5 ((b)(4)) and 3.5 mm locking screw guide ((b)(4)) were noticed broken.No case involved.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: HUMERAL RULER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• MDR Report Key: 11593503
• Report Number: 1020279-2021-02559
• Device Sequence Number: 3474025
• Product Code: HSB
• UDI-Device Identifier: 03596010514714
• UDI-Public: 03596010514714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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: 71751126
• Device Catalogue Number: 71751126
• Device Lot Number: 19CST0003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1