MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH PIN GUIDE FEMORAL L; TRUMATCH INSTRUMENTS : DRILL GUIDES

Catalog Number	420902
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Investigation summary: the device associated with this report was not returned for evaluation.No evidence was found indicating product error was a contributing factor to the reported event.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.The 420902 trumatch pin guide femoral l, lot number 099cm associated with this report was not returned for evaluation.A device history record (dhr) review found no deviations or anomalies were noted.A product development design file review was conducted by trumatch engineering.The results were as follows: segmentation: segmentation designed within trumatch specifications.Proposal design: patient has unique femur anatomy.Designer worked with checker on anterior cut with trumatch¿s anterior cortex notching visual guide.Designer and checker determined case is not notching and the bone material is osteophyte.They extruded saw blade cut past osteophyte to exit bone properly.Designer called rep to discuss sizing.Surgeon was aware of unique patient anatomy.Trumatch was notified from field after surgery that surgeon did not clear anterior soft tissue.Note on cover page of proposal states ¿a femoral deformity slightly superior to the anterior flange may cause saw blade interference.Please use caution when making anterior cut to avoid notching.¿ surgeon approved case ¿as is¿.Block design: block designed within trumatch specifications.No evidence was found indicating product error was a contributing factor to the reported event and the need for corrective action was not indicated.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.
Event or Problem Description
Trumatch cases (b)(4) did not perform as expected.It was discussed that the surgeon did not clear the anterior soft tissue of the femur.Per our surgical technique, it is recommended to clear extraneous soft tissue from the anterior aspect of the femur.

• Brand Name: TRUMATCH PIN GUIDE FEMORAL L
• Common Device Name: TRUMATCH INSTRUMENTS : DRILL GUIDES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8331231
• Report Number: 1818910-2019-84137
• Device Sequence Number: 13876058
• Product Code: JWH
• UDI-Device Identifier: 10603295384779
• UDI-Public: 10603295384779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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 Catalogue Number: 420902
• Device Lot Number: 099CM
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1