MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER, 5MM, 33CM; NEEDLE HOLDER, REUSABLE

Model Number	26173KL
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected medical device was returned to the manufacturer.Further information about the incident has been requested, but was not yet received.The investigation is pending.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(4): part of the instrument dropped inside patient's body.User reported that the needle holder jaw connector broke during surgery.An x ray was done but the jaw connector could not be detected.It is suspected that a foreign part from the instrument remained in the patient's body.There is not yet enough information available to classify the health impact or if any occurred.(mfr's.Internal complaint # (b)(4)).
Additional Manufacturer Narrative
The affected 26173kl macro needle holder was investigated by the manufacturer.It can be confirmed that the needle holder has a mechanical damage at the distal end.A piece of the tie rod from the mechanism of the movable jaw has torn/ broken off and the tie rod is also twisted.Based on the damage pattern found during the investigation, it is concluded that the most probable root cause for the breakage and the twisting of the tie rod has been a mechanical overload.The force effects causing this overload could potentially have resulted from clamping a larger part than intended with the jaw of the needle holder.In the instruction manual for needle holders, the following safety-relevant information is stated: "warning: risk of injury to the patient/ user: overloading the instrument (as a result of applying or exerting too much force on it) may cause the medical device to break, bend, and malfunction, and consequently injure patients or users.Never overload the instrument.Do not bend bent instruments back to their original position (tensile crack lead to corrosion).".
Event or Problem Description
Further received information: patient was explained different treatment possiblities by the primary consultant on 11 jan during the morning rounds.Patient opted for conservative management and watchful waiting as the patient is currently well and asymptomatic, and balancing risks/benefits of surgery to retrieve foreign body.The foreign body is at l5 vertebral body, to the right of the spinous process of the vertebra.It is currently still within the patient's body as she has opted for conservative management.The patient was clinically well and stable and discharged home well on (b)(6) 2022.(mfr's.Internal complaint (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5MM, 33CM
• Common Device Name: NEEDLE HOLDER, REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 13423417
• Report Number: 9610617-2022-00016
• Device Sequence Number: 14778361
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 4048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

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: 26173KL
• Device Catalogue Number: 26173KL
• Device Lot Number: NR01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2018
• 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: Other
• Patient Sex: Unknown