MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 10 FRENCH DRAIN SYSTEM STERIL; INSTRUMENT

Model Number 6648

Device Problems Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.If additional information is received it will be reported on a supplemental report.The product was discarded by the facility at their location.

Event Description

It was reported by a distributor that after an initial surgery was completed a revision surgery took place to remove a drain that broke off inside a patient's knee.The initial surgery was reported as completed successfully, and there is no further information available regarding the revision surgery.

Event Description

It was reported by a distributor that after an initial surgery was completed a revision surgery took place to remove a drain that broke off inside a patient's knee.The initial surgery was reported as completed successfully, and there is no further information available regarding the revision surgery.

Manufacturer Narrative

Based on the provided images of the complaint product, the reported event could be confirmed.Initially, the customer thought the complaint product ¿10 french drain system steril¿ with catalog # 6648 and lot # m1702022 was produced by medline industries inc.Therefore, this product was sent to medline industries inc.For investigation.Within their investigation report, documented by complaint # (b)(4) and forwarded to stryker, it is stated that the customer reported ¿the drain snapped while being removed from the patients left knee¿.During visual inspection of the complained product it was found that the breakage sight was uneven.It snapped from one side to the other and there was no ¿clean¿ separation.It was additionally noticed that based on the appearance of the drain and the reservoir bulb, the complained product was not manufactured by medline industries inc.The case was forwarded to the medline regulatory affairs team, and the product was eventually disposed according to the medline¿s protocol on biohazardous samples.Photos that were taken of the item were also forwarded to stryker.Within the figure 1 it is visible that the drainage catheter is broken in the section that incorporates the holes.Moreover, it can be noticed that the breakage sight is uneven (see fig.2).There is no ¿clean¿ separation that split the drain into two parts.This is an indication that excessive force was applied to the drainage catheter during removal.Finally, the part of the drainage system that is connected to the reservoir bulb including the connector does seem to be undamaged (see fig.3).The complete investigation report of medline industries inc.Is added to the trackwise attachment section of this current investigation record.The device was manufactured by stryker orthobiologics in malvern (usa).Therefore, the available complaint information was forwarded to the manufacturing site to review the related quality and manufacturing documents.All relevant documents have been reviewed by the supplier.The device history record for the ¿10 french drain system steril¿, catalog # 6648, lot code # m1702022 indicates 20 units were manufactured to specification and accepted into final stock on 2017-jun-06 with no reported discrepancies.Summarizing all obtained information, the root cause for the reported event ¿broken drainage catheter¿ is linked to a user-related issue.During removal of the catheter excessive force was applied, resulting in an uneven breakage of the silicone rubber, as it is illustrated in the images of the complaint product.Based on the investigation and the corresponding statistical evaluation, the dhr review of the relevant quality and manufacturing documents, as well as, based on the provided images of the complaint product, there is no indication for a not correctly working product or any systematic design, material, or manufacturing-related issue.Therefore, no further corrective and/or preventive actions are deemed necessary at that time.The complaint is added to the complaint trend.

• Brand Name: 10 FRENCH DRAIN SYSTEM STERIL
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 9284203
• MDR Text Key: 165235589
• Report Number: 0008010177-2019-00067
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 37613252088463
• UDI-Public: 37613252088463
• Combination Product (y/n): N
• PMA/PMN Number: K833586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6648
• Device Catalogue Number: 6648
• Device Lot Number: M1702022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1