MAUDE Adverse Event Report: AESCULAP AG CASPAR DISTRACTION PIN 14MM; SPINE SURGERY

Model Number	FF904SB
Medical Device Problem Codes	Contamination (1120); Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
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 ag that a caspar distraction pin 14mm (part # ff904sb) was used during an anterior cervical spinal procedure performed on (b)(6) 2022.According to the complainant, upon opening the packet, foreign matter was noted to be adhered to the pin.An additional medical intervention was required.There was a surgical delay during which the sterile area was reestablished.A 12mm screw was used instead.Additional information was not available.The adverse event / malfunction 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.
Event or Problem Description
It was reported to aesculap ag that a caspar distraction pin 14mm (part # ff904sb) was used during an anterior cervical spinal procedure performed on (b)(6) 2022.According to the complainant, upon opening the packet, foreign matter was noted to be adhered to the pin.An additional medical intervention was required.There was a surgical delay during which the sterile area was reestablished.A 12mm screw was used instead.Additional information was not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation: visual investigation: at first we made a visual inspection of the distraction pin and its clip-blister.Here we found no foreign particles or soiling.In the next step we investigated the primary blister.Even here we found no particles or abrasion signs, which could be hints for the occurrence or the root cause for particles.In the poly bag which was labeled with "fibrous foreign matter" we found no particle.A picture was provided of the complained particle.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 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: during the inspection we found no particle in the provided bags, therefore a further investigation was not possible.For similar cases in the future, we ask that you wrap any particles in aluminum foil and not send them in polybags, as outgassing from plastic containers can affect the sample and thus falsify the analysis result.Conclusion and measures / preventive measures: based upon the investigation results, the root cause of the reported issue can be traced back to a manufacturing-related failure.Based upon the investigation results, a capa is not necessary.
Event or Problem Description
Clarification: an additional medical intervention was required.

• Brand Name: CASPAR DISTRACTION PIN 14MM
• Common Device Name: SPINE SURGERY
• 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: 13518573
• Report Number: 9610612-2022-00021
• Device Sequence Number: 4384745
• Product Code: LXH
• UDI-Device Identifier: 04038653364305
• UDI-Public: 4038653364305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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 Expiration Date: 09/28/2025
• Device Model Number: FF904SB
• Device Catalogue Number: FF904SB
• Device Lot Number: 52639069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 02/11/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female