MAUDE Adverse Event Report: SYNTHES GMBH FIBER OPTIC LIGHT CABLE; RETRACTOR, FIBEROPTIC

Model Number	03.612.031
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a synthes employee.Part number: 03.612.031, synthes lot number: 6467768, supplier lot number: n/a, release to warehouse date: 10 nov 2010, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image.The image was reviewed, and no cracks or broken features were observed with the cable since the device was not returned, a dimensional inspection and a functional test were not able to be performed.Conclusion: the complaint condition could not be confirmed during the photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during the investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the light source cable was tested to verify its condition.The cable had micro-breaks that let the light escape.There was no involvement with the patient, no delays, or adverse events.This report is for one (1) fiber optic light cable.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: a product investigation was conducted.Visual inspection: the fibre optic cable f/light strip (p/n: 03.612.031, lot #: 6467768) was returned and received at us cq.Upon visual inspection, no defects were observed with the returned device.Functional test: the functional test was performed on the returned device.The light source was directed on one end of the cable and it was identified that the fiber on the other end of the cable had dark spots.The dark spots can be related to poor light transmission due to internal damage to the cable.Thus, the complaint condition can be replicated.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture of the relevant drawings, the current and manufactured revision of drawings were reviewed investigation conclusion: the complaint condition was confirmed for the fibre optic cable f/light strip (p/n: 03.612.031, lot #: 6467768).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.H3, h6: a device history record (dhr) review was conducted: part number:03.612.031, synthes lot number: 6467768, supplier lot number: n/a, release to warehouse date: 10nov2010, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Part # 03.612.031, synthes lot # 6511464, supplier lot # 6511464, release to warehouse date: 09 nov 2010, supplier: (b)(4).Ncr was generated during production due to part not being etched correctly.Should have been etched with part # 03.612.031 and was etched with 3.612.031.This non-conformance is not related to the complaint condition of the cable has micro-breaks that let the light escape.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: FIBER OPTIC LIGHT CABLE
• Common Device Name: RETRACTOR, FIBEROPTIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf PA 4436 ; SZ 4436
• MDR Report Key: 11783287
• Report Number: 2939274-2021-02232
• Device Sequence Number: 19878963
• Product Code: FST
• UDI-Device Identifier: 10705034714530
• UDI-Public: 10705034714530
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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 Model Number: 03.612.031
• Device Catalogue Number: 03.612.031
• Device Lot Number: 6511464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1