MAUDE Adverse Event Report: SYNTHES GMBH CONNEC L141 F/INSERTION HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.047
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that, the thread of the insertion handle arrived damaged and did not thread well.This report is for one (1) connec l141 f/insertion handle.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images attached to the email attached in the notes & attachments section of pc titled "source file - novedad pieza colectivo 286184".The images were reviewed, and the complaint condition is not confirmed.There is no visible damage to the threads of the driving cap.As the physical device was not received, a functional test could not be performed and therefore it cannot be confirmed that device has dysfunctional threads.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.,background: the piece arrived damaged and cannot be used.The thread is in bad condition and did not thread well, so it could not be used.This complaint involves one (1) device.Visual inspection: the device (connec l141 f/insertion handle, product code: 03.010.047 lot #: 9873266) was returned and received at cq.Upon visual inspection, it was observed that the threads in the device were damaged.No other issues were identified.Functional testing: due to the damaged threads, the driving cap body cannot be totally threaded in the handle adaptor.Dimensional inspection: dimensional analysis was not performed due to the post-manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion the complaint condition was confirmed for the returned device.No definitive root cause could be determined based on the provided information.The unintended external forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - product code: 03.010.047 lot number: 9873266 manufacturing site: hagendorf release to warehouse date: 27 may 2016 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONNEC L141 F/INSERTION HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13569078
• Report Number: 8030965-2022-01025
• Device Sequence Number: 19815096
• Product Code: LXH
• UDI-Device Identifier: 07611819760844
• UDI-Public: (01)07611819760844
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.047
• Device Lot Number: 9873266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2016
• 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
• Patient Sex: Unknown