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
Event or Problem Description
It was reported to aesculap ag that a jaw ins.Bip.Maryland diss.Fcps 5/310mm (part # pm431r) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, a tiny piece of the instrument 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.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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.A tiny part of the jaw insert broke off and fell into the patient.No mention of any delay in surgery.
Additional Manufacturer Narrative
Investigation results: visual investigation: at the first sight the instrument shows no defects or damages.We made a visual inspection of the jaw and its ceramic insulation.We found the insulation cracked and damaged at several points.The broken parts were not enclosed.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: without further knowledge about the circumstances we assume, that a too high force was applid on the jaw during surgery.A material failure or a manufacturing error can be excluded.Conclusion and measures / preventive measures: due to the current deviation and according to the explanation above, the root cause of the problem is most probably usage-related.Based upon the investigations results a capa is not 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
• 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: 12909239
• Report Number: 9610612-2021-00745
• Device Sequence Number: 4946703
• Product Code: GEI
• UDI-Device Identifier: 04038653208630
• UDI-Public: 4038653208630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021; 02/08/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/01/2021; 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female