MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN EXTREMITY IMPLANT; SHOULDER INSTRUMENT/TRIAL

Catalog Number UNK EXTREMITY

Device Problem Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

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 the rotation indicated by the version rod did not match the humeral head anatomy and the placement of the cutting guide with the kit in question was indicating an incorrect cut.When the alternative kit was opened and used on the same patient in the same way, the cut was positioned correctly with regards to the patient's anatomy.There is no obvious defect with the kit however the hospital have requested that this kit is swapped out.

Manufacturer Narrative

Additional narrative: the complaint description states that the rotation indicated by the version rod did not match the humeral head anatomy and the placement of the cutting guide with the kit in question was indicating an incorrect cut.No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the returned devices were reviewed by r & d (shoulders) and a report was received stating; for the analysis of (b)(4), the superior- lateral cutting guide was correctly assembled with the cutting plate and then affixed to a cutting handle exactly as illustrated in the delta xtend technique guide.All five sizes of the cutting handle were inspected, with only the 10mm code shown in the photos below.Using a simulated anatomical model, the orientation pin was passed through the hole in the cutting handle at the desired retroversion.This pin is aligned in the direction of the forearm, as expected.There was no issue with the correctly assembled instrumentation.The issue seen in the operating room may have been caused by incorrect assembly of the superior -lateral cutting guide or not correctly seating the cutting handle on the cutting guide.If this were to be incorrectly assembled, the desired retroversion would not be possible, as stated in the original complaint.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Complaint description: it was reported that the rotation indicated by the version rod did not match the humeral head anatomy and the placement of the cutting guide with the kit in question was indicating an incorrect cut.When the alternative kit was opened and used on the same patient in the same way, the cut was positioned correctly with regards to the patients anatomy.There is no obvious defect with the kit however the hospital have requested that this kit is swapped out./ | investigation method: product analysis no product returned dhr review not performed as no lot n° was provided no other analysis was possible because the product codes and batch numbers were not provided.Based on the information received and the investigation performed, the root cause of the incident could not be determined./ | investigation summary: the complaint description states that the rotation indicated by the version rod did not match the humeral head anatomy and the placement of the cutting guide with the kit in question was indicating an incorrect cut.The devices associated to the complaint were not returned for analysis.No other analysis was possible because the product codes and batch numbers were not provided.Based on the information received and the investigation performed, the root cause of the incident could not be determined.

• Brand Name: UNKNOWN EXTREMITY IMPLANT
• Type of Device: SHOULDER INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthpedics drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 6943548
• MDR Text Key: 89696594
• Report Number: 1818910-2017-26389
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK EXTREMITY
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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