MAUDE Adverse Event Report: AESCULAP AG ACETABULAR REAMER HEAD STANDARD D52MM; HIP ENDOPROSTHETICS

Model Number NF952R

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/19/2022

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 nf952r - acetabular reamer head standard d52mm.According to the complaint description, after reaming with the correctly chosen size, the 52mm cup did not fit.Next, the 54mm trial was fit in place, and the 54 mm plasma cup was implanted instead.It was noted that the 54mm reamer had not been used.There was an additional medical intervention.A larger cup than originally planned was implanted in the patient.Additional information was not provided.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: nf950r - acetabular reamer head standard d50mm (b)(4).

Manufacturer Narrative

Investigation: visual investigation: the two (2) reamers were sent to the mc department for investigation and functional check.Result: there are no deviations regarding size/dimensions on both reamers.The cutters are relatively old with partly blunt/damaged, depressed cutting edges.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 2/3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale no failure regarding size/dimensions on both reamers could be determined.Suspected size discrepancy of profiler cannot be confirmed.Most probably, the larger milling in the acetabulum during application was caused by the increased force due to the damaged/blunt cutting edges.Therefore,extract from instructions for use (ifu) applies; after each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and free of damage (e.G.Broken insulation or corroded, loose, bent broken cracked, worn, or fractured components).Massive rotational movements to remove material could have additionally intensified this.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results, a capa request is not necessary.

Event Description

Update: this malfunction occurred in th course of total hip arthrplasty with bicontact.Associated medwatch reports: nf952r (9610612-2022-00259) 400566331; nf950r (9610612-2022-00359) 400566332.

• Brand Name: ACETABULAR REAMER HEAD STANDARD D52MM
• Type of Device: HIP ENDOPROSTHETICS
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15391206
• MDR Text Key: 299588642
• Report Number: 9610612-2022-00259
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NF952R
• Device Catalogue Number: NF952R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NF950R - ACETABULAR REAMER HEAD STANDARD D50MM.
• Patient Outcome(s): Required Intervention