MAUDE Adverse Event Report: 3006356043 JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 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 08/26/2014

Event Type  Injury  

Event Description

After closing the hip the surgeon realized through xray that one of the screws was placed through the apex hole.The surgeon decided to open the hip back up to remove the screw and had to change the poly as well.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

After closing the hip the surgeon realized through x-ray that one of the screws was placed through the apex hole.The surgeon decided to open the hip back up to remove the screw and had to change the poly as well.Dos (b)(6) 2014.The device associated with this report was not returned.A complaint database search finds no other reported incidents against the provided product and lot combination.The investigation could not verify or identify any product contribution to the reported event.The root cause is attributed to inadvertent use error.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: PINN CAN BONE SCREW 6.5MMX25MM
• Type of Device: HIP OTHER IMPLANT
• Manufacturer (Section D): 3006356043 JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no.299 changyang st; suzhou industrial park; suzhou 2151 2-6; CH 21512-6
• Manufacturer (Section G): 3006356043 JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.; no.299 changyang st; suzhou industrial park; suzhou 2151 2-6; CH 21512-6
• Manufacturer Contact: stacey trick ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714554
• MDR Report Key: 4076726
• MDR Text Key: 4855104
• Report Number: 1818910-2014-27622
• 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
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 121725500
• Device Lot Number: D14040762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR