MAUDE Adverse Event Report: AESCULAP AG TSPACE PEEK/XP INSERTION INSTRUMENT; INSTRUMENTS INTERBODY FUSION

Model Number	SN305R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a tspace peek/xp insertion instrument (part # sn305r) was used during a procedure performed on (b)(6) 2021.According to the complainant, a metal sheath has fallen off during surgery.Inserts for t-space work without problems during the operation.Subsequently during cleaning of instrument, it is found that one metal cap is missing.A weld was broken and the metal sheath has fallen off.Cannot be found despite intense search.X-rays postoperatively showed the metal sheath was not present within patient.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
According to our reevaluation, this event is considered reportable for the following reason, despite the fact that no actual patient injury was reported: the reporting decision is based upon the review of the applicable risk analysis.Investigation results: visual investigation: a part of the locking mechanism is missing.The missing part was not enclosed.During a visual inspection we found, that the welding seam of the locking mechanism is broken.The problem of the breaking welding seam is known and a design change was launched in 2017.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5)x probability of occurrence 2(5) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results this incident was caused due to a design-related failure.To avoid the recurrence, a design change was already initiated and implemented in 2017.The modified instruments no longer show this error.Based upon the investigations results a capa is not necessary.

• Brand Name: TSPACE PEEK/XP INSERTION INSTRUMENT
• Common Device Name: INSTRUMENTS INTERBODY FUSION
• 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: 13509341
• Report Number: 9610612-2022-00005
• Device Sequence Number: 17153688
• Product Code: LXH
• UDI-Device Identifier: 04046964479137
• UDI-Public: 4046964479137
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: SN305R
• Device Catalogue Number: SN305R
• Device Lot Number: 52302066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2017
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown