MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD CLAMP; MISC ORTHO SURGICAL INSTR

Model Number	299704175
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: rod clamp was received at us cq.Upon visual inspection at cq, it is observed that there were few rust spots found at multiple places on the surface of the device.There were few scratches and discolored spots found on the surface of the device.Thus, the complaint is being confirmed.Document/ specification review: the relevant drawings were reviewed during investigation: no design issues were found which can contribute to this complaint condition.Investigation conclusion: a visual inspection, and document/ specification review were performed as part of this investigation.The complaint is being confirmed as there were few rust spots found on the surface of the device.While a definitive root cause could not be determined, it is possible that the present complaint condition might be due to improper maintenance or sterile processing.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.A device history record (dhr) review was conducted: a review of the receiving inspection (ri) for rod clamp was conducted identifying that lot number gm4955801 was released in three batches.Batch 1: lot qty of (b)(4) units were released on (b)(6) 2017 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on (b)(6) 2017 with no discrepancies.Batch 3: lot qty of (b)(4) units were released on (b)(6) 2017 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 synthes reports an event in (b)(6) as follows: it was reported that the expedium instruments are showing pitting corrosion.This was noticed in central sterile service department (cssd).There was no patient involvement reported.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ROD CLAMP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9384475
• Report Number: 1526439-2019-52519
• Device Sequence Number: 2219898
• Product Code: LXH
• UDI-Device Identifier: 10705034467313
• UDI-Public: (01)10705034467313
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 299704175
• Device Catalogue Number: 299704175
• Device Lot Number: GM4955801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1