MAUDE Adverse Event Report: JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043 PINN CAN BONE SCREW 6.5MMX25MM; HIP OTHER IMPLANT

Catalog Number 121725500

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 07/14/2014

Event Type  malfunction  

Manufacturer Narrative

Visual examination of the returned products is unable to confirm the reported event; the two returned components were not stuck together.A functional check found the returned products functioned as intended.It's possible the end user pushed the tapered hex of the screwdriver too far into the head of the screw.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

The hex end of the cardan screw driver became lodged or stuck in the female hex of the cancelloous screw.It was difficult to disassemble and in doing so compromised the screw.

Manufacturer Narrative

Additional narrative: this complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 2151 2-6; CH 21512-6
• Manufacturer (Section G): JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou, jiangsu 2151 2-6; CH 21512-6
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 3937282
• MDR Text Key: 11952016
• Report Number: 1818910-2014-23497
• Device Sequence Number: 1
• Product Code: NDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK983014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121725500
• Device Lot Number: D14013178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 65