MAUDE Adverse Event Report: INTEGRA YORK, PA INC. APPEL NH 5MM LEFT-CURVE

Catalog Number 600250

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A failure analysis and determination of root cause is not possible due to the lack of information received to perform a complete investigation.Product has not been returned.The reported complaint is unconfirmed.The lot /serial number was not provided to perform dhr review.Unique device identifier: (b)(4).

Event Description

A medwatch with uf/importer report number (b)(4) received on 10apr2019 with the following information: a 600250 appel nh left-curve tungsten carbide tip was missing, (2cm x 1cm shaving from the inner aspect).Additional information received on 15apr2019 indicated that the event occurred on (b)(6) 2019.The patient was prepped for surgery; however, the tip issue was discovered prior to use on the female patient.The device was unable to grip a needle.There was a 5-minute surgery delay with no adverse consequences to the patient.There was no revision or medical intervention required.

• Brand Name: APPEL NH 5MM LEFT-CURVE
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8570606
• MDR Text Key: 144003674
• Report Number: 2523190-2019-00065
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K931928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 600250
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/01/2019
• 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