MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB 2 DEG BROACH 37MM; KNEE INSTRUMENT : BROACHES

Model Number	2178-63-111
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During the operating the doctor found the following defects: on sleeve broach 37 the card stems cannot be put on it.It did not affect the patient and the or was able to take place.Part number 860284 needs to be replaced it no longer torqued.It did not affect the patient and the or was able to take place.Article number 201103080 is defective.The plastic is torn on the inside.It did not affect the patient and the or was able to take place.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > examination of the returned device confirmed the reported event.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.Device history lot = > previous investigations found the black ¿o¿ ring used to secure the mating trial stem has stiffer mechanical properties as compared to the standard orange ¿o¿ ring components.The complaints identified for this failure mode involved broaches that were manufactured in 2004 and 2005.The stiffer mechanical properties of the black ¿o¿ ring make assembly with the mating stem trials difficult and sometimes impossible.The root cause is being attributed to supplier manufacturing utilizing the black ¿o¿ ring.All o-rings should meet the print specification of shore a hardness 50 (durometer specification).Broaches should utilize o-ring seal 90000b21-02, which controls the amount of force needed to insert the mating component into the broach.The vendor (tecomet) was contacted and supplied new o-rings for examination.The new o-rings allowed the broach to connect to the mating component with the appropriate force.The new o-rings were also orange in color and softer than the black o-rings in the complaint products.No corrective action required, as supplier corrective action taken was previously implemented.The supplier has updated the method to obtain o-rings from the specified material and source.All broaches manufactured beginning in january 2007 will use the correct o-ring.

• Brand Name: MBT REV TIB 2 DEG BROACH 37MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11691368
• Report Number: 1818910-2021-08268
• Device Sequence Number: 11545266
• Product Code: HTQ
• UDI-Device Identifier: 10603295096085
• UDI-Public: 10603295096085
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2021

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: 2178-63-111
• Device Catalogue Number: 217863111
• Device Lot Number: A0605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 05/03/2021; 06/25/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 05/16/2021; 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1