MAUDE Adverse Event Report: I.T.S. GMBH SYMPHYSIS PLATE, 6-HOLE

Model Number	21161-6
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a symphysis plate 6-hole broke 2 months post-op two times after fixation of a symphysis disruption.Plate breakage was noticed during routine x-ray.
Additional Manufacturer Narrative
As no lot no.Was provided, we have inspected the batch documentation of lots that were sent to the hospital and no deviation was detected.From each lot we had one piece physically in the warehouse and we have as well re-checked these items and no deviation to the defined specifications were detected.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.

• Brand Name: SYMPHYSIS PLATE, 6-HOLE
• Common Device Name: SYMPHYSIS PLATE, 6-HOLE
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 12932327
• Report Number: 3004369035-2021-00009
• Device Sequence Number: 5411821
• Product Code: HRS
• UDI-Device Identifier: 09120034302961
• UDI-Public: 09120034302961
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 21161-6
• Device Catalogue Number: 21161-6
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown