MAUDE Adverse Event Report: B.BRAUN SURGICAL SA BONE WAX 24X2.5G; BIOSURGICALS

Model Number 1029754

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: none, pictures received showing the defect.Analysis and results: there are no previous complaints of this code batch of which (b)(4) units were manufactured and distributed in the market.There are no units in stock in the warehouse.No samples have been received but pictures attached shows a secondary packaging with a primary packaging without product.Between the different orders empty packages are driven to exclude a mixing with the respective orders.These empty units should be discarded by the personnel in production.Reviewed the batch manufacturing records this product had a normal process and results during process fulfilled the oem specifications.Taking into account that no other complaints have been received regarding this issue, it is considered that this is an isolated and accidental issue.Final conclusion: taking into account that the results of samples received do not fulfill the oem specifications, it is concluded that the complaint is justified.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.This report is being submitted late due to mis-interpretation of 2 year presumption acknowledgement and agreement by fda.Once issue was identified, retrospective review of complaints was completed from time of 2 year presumption implementation to present.All reports identified are being reported.

Event Description

Country of complaint: (b)(6).It is reported that there's no product inside the package.

• Brand Name: BONE WAX 24X2.5G
• Type of Device: BIOSURGICALS
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7522958
• MDR Text Key: 108754743
• Report Number: 3003639970-2018-00278
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1029754
• Device Catalogue Number: 1029754
• Device Lot Number: 216271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Distributor Facility Aware Date: 04/25/2018
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other