MAUDE Adverse Event Report: AESCULAP AG S4 POLYAXIAL SCREW 7.5X50MM CANULATED; MPLANTS POSTERIOR STABILISATION

Model Number SW367T

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: no product, and no product at hand reported.The manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this batch and error pattern at hand.Because there are neither a product not further information available, a definitive root cause cannot be determined.

Event Description

It was reported by the healthcare professional to the company sales representative "upon receipt of the box of materials in the cme, it was verified that there were 02 screws with dirt, characterizing previously used material.Screw cannulated powder 7.5x50 lot 52120964 screw powder cannulated 4.5x30 lot 51853111".All med watch submissions related to this report are: 9610612-2018-00422, 9610612-2018-00423 (this report).

• Brand Name: S4 POLYAXIAL SCREW 7.5X50MM CANULATED
• Type of Device: MPLANTS POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7908032
• MDR Text Key: 121713214
• Report Number: 9610612-2018-00423
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K071945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/25/2018

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 Model Number: SW367T
• Device Catalogue Number: SW367T
• Device Lot Number: 52120964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/10/2018
• Device Age: 3 YR
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1