MAUDE Adverse Event Report: AESCULAP AG MINOP REPLACEMENT PART F/FF388R; OR TECHNOLOGY NEURO

Model Number FF438R

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 01/25/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with minop replacement part.According to the customer report: "item tip broke off during surgery.Broken piece was retrieved and medical imaging contacted:" this incident did not cause or contribute to serious injury or death.There was a delay in critical therapy.An additional medical intervention was necessary.The adverse event is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: change of the article from ff388r to ff438r.We received the pull-rod ff435202 for investigation decontaminated but no other component.Failure description- only the pull-rod ff435202 is available for investigation, but the jaw part ff435203 was not provided.Investigation: the analysis of the fracture pattern illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.The breakage was most likely caused by an overload situation, e.G.Caused by due to a too high tractive force and/or torsion during handling.Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale: the breakage was most likely caused by an overload situation, e.G.Caused by a too high tractive force and/or torsion during handling.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.

• Brand Name: MINOP REPLACEMENT PART F/FF388R
• Type of Device: OR TECHNOLOGY NEURO
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9732988
• MDR Text Key: 181641591
• Report Number: 9610612-2019-00965
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• PMA/PMN Number: K983365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF438R
• Device Catalogue Number: FF438R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention