MAUDE Adverse Event Report: AESCULAP AG S4 AIMING DEVICE F/KIRSCHNER BORING WIRE; INSTRUMENTS POSTERIOR STABILIS

Model Number FW258R

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the instrument arrived in a decontaminated condition.A microscopic investigation of the working tip, especially of the fracture surface.The fracture surface shows the typically hints for a forced brittle fracture under bending load, further we noticed a crack in the shaft, starting from the fracture site.A measuring of the tip rest shows, that about 8 mm of the tip are missing.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 lot at hand.The root cause for the problem is most probably usage related.A capa is not necessary.

Event Description

It was reported by the healthcare professional to the company sales representative "during insertion of a cannulated pedicle screw, the tip of the guide wire broke off and remained in the bone." customer clarification update: the s4 system instruments were used for this surgery: leading component: fw258r s4 aiming device f/kirschner boring wire during insertion the tip of the sleeve of the aiming device broke off.Involved component: fw271r s4 trocar f/canulated screws.Additional information submitted: it was reported that no fragments were retrieved, they remained in situ.The patient was restored without any consequences with no additional medical intervention provided.

• Brand Name: S4 AIMING DEVICE F/KIRSCHNER BORING WIRE
• Type of Device: INSTRUMENTS POSTERIOR STABILIS
• 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: 7975677
• MDR Text Key: 124070735
• Report Number: 9610612-2018-00471
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FW258R
• Device Catalogue Number: FW258R
• Device Lot Number: 52134715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/08/2018
• Device Age: 3 YR
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2015
• 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
• Patient Outcome(s): Other