MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM; REUSABLE INSTRUMENTS

Model Number	PM431R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap inc.That a jaw ins.Bip.Maryland diss.Fcps 5/310mm (part # pm431r) was used during a laparoscopic bilateral salpingo-oophorectomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a tiny part of the jaw insert broke off and fell into the patient.The surgeon was able to retrieve the fragment, and then the procedure was continued and successfully completed.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.No mention of any delay in surgery.The adverse event is filed under (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was returned to the manufacturer for evaluation.A visual examination of the jaw and ceramic insulation was performed.The insulation was found to be cracked and damaged at several points.The broken parts were not enclosed.The device history records (dhr) were reviewed for the available lot number; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Additionall, there were no similar complaints against the same lot number with this error pattern.Explanation and rationale: without further knowledge about the event circumstances, the failure was suspected to have been caused by the application of too high a force on the jaw during surgery.A material failure and a manufacturing error have been excluded.The most probable root cause was reported as being usage related.Based upon the investigations results a capa is not necessary.
Event or Problem Description
No changes necessary.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FCPS 5/310MM
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12909606
• Report Number: 2916714-2021-00227
• Device Sequence Number: 5085687
• Product Code: GEI
• UDI-Device Identifier: 04038653208630
• UDI-Public: 4038653208630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022
• Report Date (Section F): 12/01/2021

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
• Operator of Device: Health Professional
• Device Model Number: PM431R
• Device Catalogue Number: PM431R
• Device Lot Number: 62333808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2021
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/03/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 12/01/2021